· Web viewthat have low oxygen levels. The oxygen levels in tumors and its effect on the tumor...

Sample consent form version: 2/25/14To be attached to protocol version: 2/25/14

Informed Consent Templatefor Cancer Treatment Trials, Inclusive of FMISO Imaging Component

(English Language)

This informed consent form template includes the treatment and imaging components of the RTOG 1106 and ACRIN 6697 trial.

RTOG 1106/ACRIN 6697

Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in

Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

[Note: Potential participants at institutions taking part in the FMISO imaging component of the study must consent to receive the FMISO-PET/CT scan described below.]

This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.

You are being asked to take part in this study because you have lung cancer.

Why is this study being done?The standard treatment for lung cancer can include radiation therapy and/or chemotherapy and/or surgery to remove the cancer. Patients like you cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. Patients who cannot have surgery for lung cancer often receive radiation therapy and/or chemotherapy.

Successful treatment of lung cancer with radiation therapy requires that doctors find out exactly where the tumor is in your body and that they protect your normal tissue. This study will use imaging called FDG-PET/CT (Fluorodeoxyglucose–Positron Emission Tomography/Computed Tomography) before treatment and again during treatment.

FDG-PET/CT is imaging that uses small amounts of a radioactive glucose (FDG) injected into your vein to make images of your neck, chest, abdomen and pelvis and areas of active cancer. A Computed Tomography (CT) scan also will be done with the PET scan to help doctors see clearly where your cancer is and what part of your lung tumor is active. Treatment based on FDG-PET/CT imaging is designed so that the dose to normal organs is the same as in the standard radiation, but the dose to the tumor can be increased.

The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of your cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. The doses to normal tissues, such as heart, spinal cord, and esophagus are strictly limited and are kept at the same safe limits as in standard radiation.

A smaller group of patients will receive an additional PET/CT scan using a different radiotracer, which is abbreviated as FMISO. The FMISO radiotracer is an investigational agent. It will show areas of the tumor that have low oxygen levels. The oxygen levels in tumors and its effect on the tumor may help predict the

1 RTOG 1106/ACRIN 6697


response of the tumor to therapy. You will receive the FMISO-PET/CT scan because it is being done as part of this trial at [Insert Institution].

How many people will take part in the study?About 138 people will take part in this study.

What will happen if I take part in this research study? (2/25/14)

Before-treatment PET/CT scansYou will have an FDG-PET/CT scan and also will have an FMISO-PET/CT scan on a separate day.

You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the two study groups. Neither you nor your study doctor can choose the group you will be in. You are twice as likely to be placed in group 2 (radiation treatment based on FDG-PET/CT) than in group 1 (standard radiation).

First part of treatment: Radiation and Chemotherapy

If you are in group 1 (often called "Arm A"), you will receive standard radiation treatment once daily, 5 days a week for 5 weeks. You also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6-7 weeks.

If you are in group 2 (often called "Arm B"), you will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. You also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6-7 weeks.

Each radiation treatment takes about 30 minutes.

Both groups: Paclitaxel and carboplatin are given by vein before radiation therapy. Before chemotherapy is given, you will receive medicines to ease possible side effects, such as upset stomach and vomiting. The paclitaxel takes one hour to be given. After the paclitaxel, the carboplatin is given over 30 minutes.

During-radiation FDG-PET/CT scan:

Both groups: You will have this imaging between weeks 3 and 4 of radiation therapy.

Second part of treatment: Finishing Radiation (Chemotherapy continues during radiation)

If you are in group 1 (often called "Arm A"), you will continue to receive standard radiation treatment once daily, 5 days a week for 1 week for a total of 6 weeks. If the during-radiation FDG-PET/CT scan shows that your disease has spread outside the chest, you may not receive further treatment because it may not be effective.

If you are in group 2 (often called "Arm B"), you will continue to receive radiation treatment based on the during-radiation FDG-PET/CT scan, once daily, 5 days a week for 1-2 weeks for a total of 6 weeks. This radiation treatment will be a higher dose per day than standard radiation. If the during-radiation FDG-PET/CT scan shows that your disease has spread outside the chest, you may not receive a higher dose per day because that dose may not be effective.




Third part of treatment: Chemotherapy Alone

Both groups: Four to six weeks after radiation treatment is completed, you will receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy. Before chemotherapy is given, you will receive medicines to ease possible side effects, such as upset stomach and vomiting. The paclitaxel takes 3 hours to be given. After the paclitaxel, the carboplatin is given over 30 minutes.

Study Plan (2/25/14)

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.

Before you begin the study: (2/25/14)You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not


Randomize

(You will be in one Group or the other)

Group 2Individualized Radiation Therapyonce a

day, M-F, for 3-4 weeks and Chemotherapy once a week for 6-7

weeks

Group 1Standard Radiation Therapy once a day,

M-F, for 5 weeks and Chemotherapy once a week for 6-7 weeks

All patients

4-6 weeks after completion of radiation,

Group 1Standard Radiation Therapy once a

day, M-F, for 1 week (with chemotherapy)

Group 2Adaptive Radiation Therapy based on during-treatment FDG-PET/CT, once a

day, M-F, for 2-3 weeks

Before-treatment FDG-PET/CT and FMISO scans

Group 1During-treatment FDG-PET/CT scanbetween weeks 4 and 5 of radiation

treatment


treatment


join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities A CT (Computed Tomography) scan of your lungs and abdomen: a CT scan is a study

using x-rays to look at one part of your body. Your doctor may use contrast, which means that dye is injected into your vein to increase the differences between normal and abnormal tissue.

An FDG-PET/CT (Positron Emission Tomography/Computed Tomography) scan of your body: A small amount of radioactive material is injected into your vein, and a scanner makes a detailed picture of areas inside your body

A CT scan or MRI (Magnetic Resonance Imaging) of your brain; An MRI is imaging that uses a strong magnetic field to look at one part of your body. Your doctor may use contrast with the CT scan.

Blood tests (about 1-2 teaspoons of your blood will be taken) Tests of your breathing and lung function For women who are able to have children, a test to see that they are not pregnantIf recommended by your doctor:

An evaluation by a lung specialist An EKG or echocardiogram, tests of your heart function A test in which radioactive material is inhaled or injected to measure breathing and

circulation in the lung An evaluation of your ability to swallow and chew and of your diet

During the study: (8/22/12)If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures.

An FMISO-PET/CT scan An FDG-PET/CT scan: For Group 1 patients between weeks 4 and 5 of radiation therapy;

for Group 2 patients between weeks 3 and 4 of radiation therapy.

Weekly during radiation treatment and chemotherapy Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities Blood tests (about 1-2 teaspoons of your blood will be taken) Evaluation of any side effects you may be having

During chemotherapy alone (after radiation) On the 1st day of each chemotherapy cycle (total of 3 cycles):

Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities Evaluation of any side effects you may be having Blood testsYou also will have some blood tests weekly.



When you are finished treatment: (8/19/13)You will be seen at 1 and 3 months after treatment, then every 6 months for years 2 and 3, then once in years 4 and 5. In these visits you will have the following tests and procedures:

Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities Blood tests (about 1-2 teaspoons of your blood will be taken) Evaluation of any side effects you may be having

You also will have: Lung function tests at 3 and 12 months after treatment A chest x-ray at 1, 3, and 9 months after treatment A CT scan of your chest and upper abdomen area every 3 months in the 1 st year and

every 6 months in the 2nd year after treatmentIf your doctor recommends: A bronchoscopy, a test in which a hollow, flexible tube is inserted through your mouth or

nose into your airway An FDG-PET/CT scan

How long will I be in the study? (8/22/12)

You will receive radiation treatment and chemotherapy for 6 weeks. Four to six weeks after completing radiation, you will receive chemotherapy for another 6 weeks.

After you finish all treatment, you will be seen at 1 month after the end of treatment, every 3 months for the first year, every 6 months for years 2 and 3, then once a year for your lifetime.

Can I stop being in the study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.

It is important to tell the study doctor if you are thinking about stopping so any risks from the chemotherapy or radiation therapy can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.

The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.

What side effects or risks can I expect from being in the study? (8/19/13)

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don’t know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop treatment. In some cases, side effects can be serious, long lasting, or may never go away. There also is a risk of death.

You should talk to your study doctor about any side effects that you have while taking part in the study.



Risks and side effects related to FDG-PET/CT scans:

The risks associated with an FDG-PET/CT scan are minimal. FDG is considered safe, and there has not been a report of side effects with this imaging. If you participate in this study, you will be receiving 2 FDG-PET/CT scans. These scans are an established diagnostic test and often performed for many kinds of cancers.

Rarely, some patients may experience a severe allergic reaction to the radioactive glucose, which can result in hives or difficulty breathing. There is a risk of discomfort, bruising, bleeding, fainting or infection with the placement or removal of the needle used for drawing blood and injecting the FDG. Some persons may find it uncomfortable to lie still on their back for up to 45 minutes.

Risks and side effects related to FMISO-PET/CT scans:

There are a few possible risks of FMISO-PET/CT scans. The most common ones are not considered serious. Any serious risks of FMISO-PET/CT scans are considered very unlikely. There is a risk of discomfort, bruising, bleeding, fainting, or infection with the placement or removal of the needle used for drawing blood and injecting the FMISO. Some people may find it uncomfortable to lie still on their back for 30 minutes.

While taking part in this research study, you will be exposed to radiation (in the form of x-rays and from the radioactive glucose and FMISO). The amount of this radiation exposure is very small in comparison to the dose of radiation that you will receive for treatment of your lung cancer. The overall radiation dose to your body from all of the PET/CT scans is approximately 36.4 mSv. The annual limit for radiation exposure for those working with radiation is 50 mSv. This is also about 10 times the natural background radiation in a year. At doses much higher than you will receive from these scans, radiation is known to increase the risk of developing cancer after many years. At the doses you will receive, it is unlikely that you will see an effect.

Possible Side Effects of Radiation Therapy to the Chest

Listed below are toxicities that a patient could experience by receiving standard radiation to the lung. Because you may receive an intensified form of radiation by participating in this study (in combination with chemotherapy), there may be side effects other than those listed below that we cannot predict.

COMMON, SOME MAY BE SERIOUSIn 100 people receiving radiation therapy, more than 20 and up to 100 may have:

Difficulty, pain, or burning sensation when swallowing, which often is temporary Tiredness, which is temporary Tanning, redness of skin, and hair loss within the treatment area, which is temporary Skin in treatment area may remain permanently dry, and chest hair may not grow back Scarring in the lung, which sometimes causes collapse of the lung Fluid collection in the lung sac



OCCASIONAL, SOME MAY BE SERIOUS In 100 people receiving radiation therapy, from 4 to 20 may have:

Cough and some difficulty in breathing (or shortness of breath) due to lung inflammation or scarring, which may be severe at times

Irritation of the heart sac Irritation of the heart muscle Injury to the tube that carries food to your stomach Injury to the tube that carries oxygen to your lungs Bleeding from injury to the large blood vessels

RARE, AND SERIOUSIn 100 people receiving radiation therapy, 3 or fewer may have:

Inflammation of the spinal cord A second cancer caused by the radiation you receive

Possible Side Effects of Paclitaxel (Table Version Date: January 23, 2013)COMMON, SOME MAY BE SERIOUS

In 100 people receiving Paclitaxel, more than 20 and up to 100 may have:

Anemia which may cause tiredness, or may require blood transfusions Infection, especially when white blood cell count is low Diarrhea, nausea, vomiting Sores in mouth which may cause difficulty swallowing Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath,

swelling of the face or throat Bruising, bleeding Pain Muscle weakness Hair loss

OCCASIONAL, SOME MAY BE SERIOUSIn 100 people receiving Paclitaxel, from 4 to 20 may have:

Heart attack or heart failure which may cause shortness of breath, swelling of ankles, and tiredness A tear or a hole in the stomach which may cause belly pain or that may require surgery Damage to the lungs which may cause shortness of breath Blood clot which may cause swelling, pain, shortness of breath

RARE, AND SERIOUSIn 100 people receiving Paclitaxel, 3 or fewer may have:

None



Possible Side Effects of Carboplatin (Table Version Date: December 12, 2012)

COMMON, SOME MAY BE SERIOUS

In 100 people receiving Carboplatin, more than 20 may have:

Hair loss Vomiting, nausea Infection, especially when white blood cell count is low Anemia which may cause tiredness, or may require blood transfusions Bruising, bleeding Belly pain

OCCASIONAL, SOME MAY BE SERIOUS

In 100 people receiving Carboplatin, from 4 to 20 may have:

Diarrhea, Constipation Numbness and tingling in fingers and toes Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath,

swelling of the face or throat

RARE, AND SERIOUS

In 100 people receiving Carboplatin, 3 or fewer may have:

Changes in vision Changes in taste Damage to organs which may cause hearing and balance problems

Reproductive risks: If you are a woman able to have children and have not been surgically sterilized (tubal ligation or hysterectomy), you must have a pregnancy test before enrolling in this study. You should not become pregnant, father a baby, or donate sperm while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. For more information about risks and side effects, ask your study doctor.

Are there benefits to taking part in the study?

Taking part in this study may or may not make your health better. While researchers hope that radiation therapy based on FDG-PET/CT imaging improves treatment of lung cancer with less damage to healthy lung tissue compared to standard radiation treatment, there is no proof of this yet. We do know that the information from this study will help researchers learn more about radiation therapy based on FDG-PET/CT imaging as a treatment for cancer. This information could help future cancer patients.



What other choices do I have if I do not take part in this study?

Your other choices may include: Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment

Talk to your study doctor about your choices before you decide if you will take part in this study.

Will my medical information be kept private?

Data are housed at RTOG Headquarters in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

The Radiation Therapy Oncology Group (RTOG) The American College of Radiology Imaging Network (ACRIN) Cardinal Health, provider of [18F]FMISO The National Cancer Institute (NCI) and other government agencies, like the Food and Drug

Administration (FDA), involved in keeping research safe for people

A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of study results. You can search this web site at any time.

[Note to Local Investigators: The above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]

[Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed by the local institution. The regulations may or may not be included in the informed consent form depending on local institutional policy.]

What are the costs of taking part in this study? (8/19/13)

You and/or your health plan/ insurance company will need to pay for some or all of the costs of treating your cancer in this study. Some health plans will not pay these costs for people taking part in studies. Check with your health plan or insurance company to find out what they will pay for. Taking part in this study may or may not cost your insurance company more than the cost of getting regular cancer treatment.

You will not be paid for taking part in this study.



What happens if I am injured because I took part in this study?

It is important that you tell your study doctor, __________________ [investigator’s name(s)], if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ [telephone number].

You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.

We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data related to this study. The Committee members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name.

In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.

Who can answer my questions about the study?

You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor __________________ [name(s)] at __________________ [telephone number].

For questions about your rights while taking part in this study, call the ________________________ [name of center] Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone number). [Note to Local Investigator: Contact information for patient representatives or other individuals in a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can be listed here.] Please note: This section of the informed consent form is about additional research that is being done with people who are taking part in the main study. You may take part in this additional research if you want to. You can still be a part of the main study even if you say ‘no’ to taking part in this additional research.

You can say “yes” or “no” to the following study. Below, please mark your choice.

10 RTOG 1106/ACRIN 6697


Consent Form for Use of Tissue and Blood for Research

About Using Tissue and Blood for Research

You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will remove some body tissue to do some tests. The results of these tests will be given to you by your doctor and will be used to plan your care.

We would like to keep some of the tissue that is left over for future research. If you agree, this tissue will be kept and may be used in research to learn more about cancer and other diseases. Please read the information sheet called " Providing your Tissue for Research" to learn more about tissue research. This information sheet is available to all at http://www.cancer.gov/clinicaltrials/resources/providing-tissue.pdf.

In addition to the tumor tissue, we would like to collect some blood for research to see if proteins in the blood can predict tumor control and your risk of developing side effects from radiation therapy. You will be asked to provide about 1 teaspoon of blood at each of the following time points: 2 weeks prior to radiation treatment, at 2 and 4 weeks during radiation treatment, and at 3 months after completion of radiation treatment (same as 1 month after completion of chemotherapy), at the same time you are having other tests required in the main part of this study.

Your tissue and blood may be helpful for research whether you do or do not have cancer. The research that may be done with your tissue and blood is not designed specifically to help you. It might help people who have cancer and other diseases in the future.

Reports about research done with your tissue and blood will not be given to you or your doctor. These reports will not be put in your health record. The research will not have an effect on your care.

Things to Think About

The choice to let us keep the left over tissue and blood for future research is up to you. No matter what you decide to do, it will not affect your care or your participation in the main part of the study.

If you decide now that your tissue and blood can be kept for research, you can change your mind at any time. Just contact us and let us know that you do not want us to use your tissue and blood. Then any tissue and blood that remain will no longer be used for research and will be returned to the institution that submitted it.

In the future, people who do research may need to know more about your health. While the doctor/institution may give them reports about your health, it will not give them your name, address, phone number, or any other information that will let the researchers know who you are.

Sometimes tissue and blood is used for genetic research (about diseases that are passed on in families). Even if your tissue and blood is used for this kind of research, the results will not be put in your health records.

Your tissue and blood will be used only for research and will not be sold. The research done with your tissue and blood may help to develop new treatments for cancer and other diseases in the future.

Benefits

The benefits of research using tissue and blood include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.

11 RTOG 1106/ACRIN 6697


Risks (8/19/13)

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.

Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included. The samples are given a code to protect your privacy before they are used. Any related information given to researchers will also be coded. Researchers will receive the code instead of any information that might directly identify you.

There can be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Even though your genes are unique, you share some of the same genes with your blood relatives.

Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that the risks to you and your family are very low, because your samples will be coded. Research results will not be returned to you or your doctor.

Very rarely health or genetic information could be misused by employers, insurance companies, and others. For example, life insurance companies may charge a higher rate based on this information.

Some states have laws to protect against genetic discrimination [Institution: List appropriate state information if your state has such laws]. A new federal law called the Genetic Information Non-Discrimination Act, or GINA is in effect. This law helps to lower the risk of health insurance or employment discrimination. The law does not include other types of misuse by life insurance, disability, or long term care insurance. To learn more about the GINA Law, please ask the study staff or check the Internet.

Making Your Choice

Please read each sentence below and think about your choice. After reading each sentence, circle "Yes" or "No". If you have any questions, please talk to your doctor or nurse, or call our research review board at __________________________ [IRB's phone number].

No matter what you decide to do, it will not affect your care.

1. I agree to have my blood collected to be used in a research study, as explained above.

Yes _______ No _______

2. My specimens may be kept for use in research to learn about, prevent, or treat cancer, as follows:

Tissue Yes No Blood Yes No

3. My specimens may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease), as follows:


4. Someone may contact me in the future to ask me to take part in more research. Yes No

12 RTOG 1106/ACRIN 6697


Where can I get more information?

You may call the National Cancer Institute's Cancer Information Service at: 1-800-4-CANCER (1-800-422-6237)

You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://www.cancer.gov/cancertopics/

For more information about PET/CT scans, you can go to ACRIN's web site at http://www.acrin.org/PATIENTS/ABOUTIMAGINGEXAMSANDAGENTS/ABOUTPETSCANS.aspx. You or your doctor can print a description of PET/CT scans from this web site.

You will get a copy of this form. If you want more information about this study, ask your study doctor.

Signature

I have been given a copy of all _____ [insert total of number of pages] pages of this form. I have read it or it has been read to me. I understand the information and have had my questions answered. I agree to take part in this study.

Participant ________________________________

Date _____________________________________

13 RTOG 1106/ACRIN 6697


APPENDIX I (Continued)

Informed Consent Template for Cancer Treatment Trials (English Language)

This informed consent form template includes the treatment component of the RTOG 1106 trial.

RTOG 1106

Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in

Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.

You are being asked to take part in this study because you have lung cancer.

Why is this study being done?The standard treatment for lung cancer can include radiation therapy and/or chemotherapy and/or surgery to remove the cancer. Patients like you cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. Patients who cannot have surgery for lung cancer often receive radiation therapy and/or chemotherapy.

Successful treatment of lung cancer with radiation therapy requires that doctors find out exactly where the tumor is in your body and that they protect your normal tissue. This study will use imaging called FDG-PET/CT (Fluorodeoxyglucose–Positron Emission Tomography/Computed Tomography) before treatment and again during treatment.

FDG-PET/CT is imaging that uses small amounts of a radioactive glucose (FDG) injected into your vein to make images of your neck, chest, abdomen and pelvis and areas of active cancer. A Computed Tomography (CT) scan also will be done with the PET scan to help doctors see clearly where your cancer is and what part of your lung tumor is active. Treatment based on FDG-PET/CT imaging is designed so that the dose to normal organs is the same as in the standard radiation, but the dose to the tumor can be increased.

The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of your cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. The doses to normal tissues, such as heart, spinal cord, and esophagus are strictly limited and are kept at the same safe limits as in standard radiation.

How many people will take part in the study?About 138 people will take part in this study.

14 RTOG 1106/ACRIN 6697


What will happen if I take part in this research study? (2/25/14)

Before-treatment PET/CT scansAll patients will have a FDG-PET/CT scan.

You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the two study groups. Neither you nor your study doctor can choose the group you will be in. You are twice as likely to be placed in group 2 (radiation treatment based on FDG-PET/CT) than in group 1 (standard radiation).

First part of treatment: Radiation and Chemotherapy

If you are in group 1 (often called "Arm A"), you will receive standard radiation treatment once daily, 5 days a week for 5 weeks. You also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6-7 weeks.

If you are in group 2 (often called "Arm B"), you will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. You also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6-7 weeks.


Both groups: Paclitaxel and carboplatin are given by vein before radiation therapy. Before chemotherapy is given, you will receive medicines to ease possible side effects, such as upset stomach and vomiting. The paclitaxel takes one hour to be given. After the paclitaxel, the carboplatin is given over 30 minutes.

During-radiation FDG-PET/CT scan:

Both groups: You will have this imaging between weeks 3 and 4 of radiation therapy.

Second part of treatment: Finishing Radiation (Chemotherapy continues during radiation)

If you are in group 1 (often called "Arm A"), you will continue to receive standard radiation treatment once daily, 5 days a week for 1 week for a total of 6 weeks. If the during-radiation FDG-PET/CT scan shows that your disease has spread outside the chest, you may not receive further treatment because it may not be effective.

If you are in group 2 (often called "Arm B"), you will continue to receive radiation treatment based on the during-radiation FDG-PET/CT scan, once daily, 5 days a week for 1-2 weeks for a total of 6 weeks. This radiation treatment will be a higher dose per day than standard radiation. If the during-radiation FDG-PET/CT scan shows that your disease has spread outside the chest, you may not receive a higher dose per day because that dose may not be effective.


Third part of treatment: Chemotherapy Alone

Both groups: Four to six weeks after radiation treatment is completed, you will receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy. Before chemotherapy is given, you will receive medicines to ease possible side effects, such as upset stomach and vomiting. The paclitaxel takes 3 hours to be given. After the paclitaxel, the carboplatin is given over 30 minutes.

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STUDY PLAN (2/25/14)

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.

Before you begin the study: (2/25/14)You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not

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Randomize

(You will be in one Group or the other)

Group 2Individualized Radiation Therapyonce a

day, M-F, for 3-4 weeks and Chemotherapy once a week for 6-7

weeks

Group 1Standard Radiation Therapy once a day,

M-F, for 5 weeks and Chemotherapy once a week for 6-7 weeks

All patients

4-6 weeks after completion of radiation,

Chemotherapy every 21 days X 3

Group 1Standard Radiation Therapy once a

day, M-F, for 1 week

(with chemotherapy)

Group 2Adaptive Radiation Therapy based on during-treatment FDG-PET/CT, once a

day, M-F, for 2-3 weeks

Before-treatment FDG-PET/CT scan


treatment


treatment


join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities A CT (Computed Tomography) scan of your lungs and abdomen: a CT scan is a study

using x-rays to look at one part of your body. Your doctor may use contrast, which means that dye is injected into your vein to increase the differences between normal and abnormal tissue.

An FDG-PET/CT (Positron Emission Tomography/Computed Tomography) scan of your body: A small amount of radioactive material is injected into your vein, and a scanner makes a detailed picture of areas inside your body

A CT scan or MRI (Magnetic Resonance Imaging) of your brain; An MRI is imaging that uses a strong magnetic field to look at one part of your body. Your doctor may use contrast with the CT scan.

Blood tests (about 1-2 teaspoons of your blood will be taken) Tests of your breathing and lung function For women who are able to have children, a test to see that they are not pregnantIf recommended by your doctor:

An evaluation by a lung specialist An EKG or echocardiogram, tests of your heart function A test in which radioactive material is inhaled or injected to measure breathing and

circulation in the lung An evaluation of your ability to swallow and chew and of your diet

During the study: (8/22/12)If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures.

A FDG-PET/CT scan: For Group 1 patients between weeks 4 and 5 of radiation therapy; for Group 2 patients between weeks 3 and 4 of radiation therapy.

Weekly during radiation treatment and chemotherapy Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities Blood tests (about 1-2 teaspoons of your blood will be taken) Evaluation of any side effects you may be having

During chemotherapy alone (after radiation) On the 1st day of each chemotherapy cycle (total of 3 cycles):

Physical examinations by several doctors Checking your weight Evaluation of your ability to carry out daily activities Evaluation of any side effects you may be having Blood testsYou also will have some blood tests weekly.

When you are finished treatment: (8/19/13)You will be seen at 1 and 3 months after treatment, then every 6 months for years 2 and 3, then once in years 4 and 5. In these visits you will have the following tests and procedures:

Physical examinations by several doctors

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Checking your weight Evaluation of your ability to carry out daily activities Blood tests (about 1-2 teaspoons of your blood will be taken) Evaluation of any side effects you may be having

You also will have: Lung function tests at 3 and 12 months after treatment A chest x-ray at 1, 3, and 9 months after treatment A CT scan of your chest and upper abdomen area every 3 months in the 1 st year and

every 6 months in the 2nd year after treatmentIf your doctor recommends: A bronchoscopy, a test in which a hollow, flexible tube is inserted through your mouth or

nose into your airway An FDG-PET/CT san

How long will I be in the study? (8/22/12)

You will receive radiation treatment and chemotherapy for 6 weeks. Four to six weeks after completing radiation, you will receive chemotherapy for another 6 weeks.

After you finish all treatment, you will be seen at 1 month after the end of treatment, every 3 months for the first year, every 6 months for years 2 and 3, then once a year for your lifetime.

Can I stop being in the study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.

It is important to tell the study doctor if you are thinking about stopping so any risks from the chemotherapy or radiation therapy can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.

The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.

What side effects or risks can I expect from being in the study? (8/19/13)

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don’t know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop treatment. In some cases, side effects can be serious, long lasting, or may never go away. There also is a risk of death.

You should talk to your study doctor about any side effects that you have while taking part in the study.

Risks and side effects related to FDG-PET/CT scans:

The risks associated with an FDG-PET/CT scan are minimal. FDG is considered safe, and there has not been a report of side effects with this imaging. If you participate in this study, you will be receiving 2 FDG-

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PET/CT scans. These scans are an established diagnostic test and often performed for many kinds of cancers.

Rarely, some patients may experience a severe allergic reaction to the radioactive glucose, which can result in hives or difficulty breathing. There is a risk of discomfort, bruising, bleeding, fainting or infection with the placement or removal of the needle used for drawing blood and injecting the FDG. Some persons may find it uncomfortable to lie still on their back for up to 45 minutes.

While taking part in this research study, you will be exposed to radiation (in the form of x-rays and from the radioactive glucose). The amount of this radiation exposure is very small in comparison to the dose of radiation that you will receive for treatment of your lung cancer. The overall radiation dose to your body from all of the PET/CT scans is approximately 28 mSv. The annual limit for radiation exposure for those working with radiation is 50 mSv. This is also about 9 times the natural background radiation in a year. At doses much higher than you will receive from these scans, radiation is known to increase the risk of developing cancer after many years. At the doses you will receive, it is unlikely that you will see an effect

Possible Side Effects of Radiation Therapy to the Chest

Listed below are toxicities that a patient could experience by receiving standard radiation to the lung. Because you may receive an intensified form of radiation by participating in this study (in combination with chemotherapy), there may be side effects other than those listed below that we cannot predict.

COMMON, SOME MAY BE SERIOUSIn 100 people receiving radiation therapy, more than 20 and up to 100 may have:

Difficulty, pain, or burning sensation when swallowing, which often is temporary Tiredness, which is temporary Tanning, redness of skin, and hair loss within the treatment area, which is temporary Skin in treatment area may remain permanently dry, and chest hair may not grow back Scarring in the lung, which sometimes causes collapse of the lung Fluid collection in the lung sac

OCCASIONAL, SOME MAY BE SERIOUS In 100 people receiving radiation therapy, from 4 to 20 may have:

Cough and some difficulty in breathing (or shortness of breath) due to lung inflammation or scarring, which may be severe at times

Irritation of the heart sac Irritation of the heart muscle Injury to the tube that carries food to your stomach Injury to the tube that carries oxygen to your lungs Bleeding from injury to the large blood vessels

RARE, AND SERIOUSIn 100 people receiving radiation therapy, 3 or fewer may have:

Inflammation of the spinal cord A second cancer caused by the radiation you receive

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Possible Side Effects of Paclitaxel (Table Version Date: January 23, 2013)COMMON, SOME MAY BE SERIOUS

In 100 people receiving Paclitaxel, more than 20 and up to 100 may have:

Anemia which may cause tiredness, or may require blood transfusions Infection, especially when white blood cell count is low Diarrhea, nausea, vomiting Sores in mouth which may cause difficulty swallowing Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath,

swelling of the face or throat Bruising, bleeding Pain Muscle weakness Hair loss

OCCASIONAL, SOME MAY BE SERIOUSIn 100 people receiving Paclitaxel, from 4 to 20 may have:

Heart attack or heart failure which may cause shortness of breath, swelling of ankles, and tiredness A tear or a hole in the stomach which may cause belly pain or that may require surgery Damage to the lungs which may cause shortness of breath Blood clot which may cause swelling, pain, shortness of breath

RARE, AND SERIOUSIn 100 people receiving Paclitaxel, 3 or fewer may have:

Possible Side Effects of Carboplatin (Table Version Date: December 12, 2012)COMMON, SOME MAY BE SERIOUS

In 100 people receiving Carboplatin, more than 20 may have:

Hair loss Vomiting, nausea Infection, especially when white blood cell count is low Anemia which may cause tiredness, or may require blood transfusions Bruising, bleeding Belly pain

OCCASIONAL, SOME MAY BE SERIOUS

In 100 people receiving Carboplatin, from 4 to 20 may have:

Diarrhea, Constipation Numbness and tingling in fingers and toes Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath,

swelling of the face or throat

20 RTOG 1106/ACRIN 6697


RARE, AND SERIOUS

In 100 people receiving Carboplatin, 3 or fewer may have:

Changes in vision Changes in taste Damage to organs which may cause hearing and balance problems

Reproductive risks: If you are a woman able to have children and have not been surgically sterilized (tubal ligation or hysterectomy), you must have a pregnancy test before enrolling in this study. You should not become pregnant, father a baby, or donate sperm while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study.

For more information about risks and side effects, ask your study doctor.

Are there benefits to taking part in the study?

Taking part in this study may or may not make your health better. While researchers hope that radiation therapy based on FDG-PET/CT imaging improves treatment of lung cancer with less damage to healthy lung tissue compared to standard radiation treatment, there is no proof of this yet. We do know that the information from this study will help researchers learn more about radiation therapy based on FDG-PET/CT imaging as a treatment for cancer. This information could help future cancer patients.

What other choices do I have if I do not take part in this study?

Your other choices may include: Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment

Talk to your study doctor about your choices before you decide if you will take part in this study.

Will my medical information be kept private?

Data are housed at RTOG Headquarters in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

The Radiation Therapy Oncology Group (RTOG) The National Cancer Institute (NCI) and other government agencies, like the Food and Drug

Administration (FDA), involved in keeping research safe for people

21 RTOG 1106/ACRIN 6697


A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of study results. You can search this web site at any time.

[Note to Local Investigators: The above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]

[Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed by the local institution. The regulations may or may not be included in the informed consent form depending on local institutional policy.]

What are the costs of taking part in this study? (8/19/13)

You and/or your health plan/ insurance company will need to pay for some or all of the costs of treating your cancer in this study. Some health plans will not pay these costs for people taking part in studies. Check with your health plan or insurance company to find out what they will pay for. Taking part in this study may or may not cost your insurance company more than the cost of getting regular cancer treatment.

You will not be paid for taking part in this study.

What happens if I am injured because I took part in this study?

It is important that you tell your study doctor, __________________ [investigator’s name(s)], if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ [telephone number].

You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.

We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data related to this study. The Committee members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name.

In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.

Who can answer my questions about the study?

You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor __________________ [name(s)] at __________________ [telephone number].

22 RTOG 1106/ACRIN 6697


For questions about your rights while taking part in this study, call the ________________________ [name of center] Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone number). [Note to Local Investigator: Contact information for patient representatives or other individuals in a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can be listed here.] Please note: This section of the informed consent form is about additional research that is being done with people who are taking part in the main study. You may take part in this additional research if you want to. You can still be a part of the main study even if you say ‘no’ to taking part in this additional research.

You can say “yes” or “no” to the following study. Below, please mark your choice.

Consent Form for Use of Tissue and Blood for Research

About Using Tissue and Blood for Research

You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will remove some body tissue to do some tests. The results of these tests will be given to you by your doctor and will be used to plan your care.

We would like to keep some of the tissue that is left over for future research. If you agree, this tissue will be kept and may be used in research to learn more about cancer and other diseases. Please read the information sheet called " Providing your Tissue for Research" to learn more about tissue research. This information sheet is available to all at http://www.cancer.gov/clinicaltrials/resources/providing-tissue.pdf.

In addition to the tumor tissue, we would like to collect some blood for research to see if proteins in the blood can predict tumor control and your risk of developing side effects from radiation therapy. You will be asked to provide about 1 teaspoon of blood at each of the following time points: 2 weeks prior to radiation treatment, at 2 and 4 weeks during radiation treatment, and at 3 months after completion of radiation treatment (same as 1 month after completion of chemotherapy), at the same time you are having other tests required in the main part of this study.

Your tissue and blood may be helpful for research whether you do or do not have cancer. The research that may be done with your tissue and blood is not designed specifically to help you. It might help people who have cancer and other diseases in the future.

Reports about research done with your tissue and blood will not be given to you or your doctor. These reports will not be put in your health record. The research will not have an effect on your care.

Things to Think About

The choice to let us keep the left over tissue and blood for future research is up to you. No matter what you decide to do, it will not affect your care or your participation in the main part of the study.

If you decide now that your tissue and blood can be kept for research, you can change your mind at any time. Just contact us and let us know that you do not want us to use your tissue and blood. Then any tissue and blood that remain will no longer be used for research and will be returned to the institution that submitted it.

23 RTOG 1106/ACRIN 6697


In the future, people who do research may need to know more about your health. While the doctor/institution may give them reports about your health, it will not give them your name, address, phone number, or any other information that will let the researchers know who you are.

Sometimes tissue and blood is used for genetic research (about diseases that are passed on in families). Even if your tissue and blood is used for this kind of research, the results will not be put in your health records.

Your tissue and blood will be used only for research and will not be sold. The research done with your tissue and blood may help to develop new treatments for cancer and other diseases in the future.

Benefits

The benefits of research using tissue and blood include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.

Risks (8/19/13)

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.

Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included. The samples are given a code to protect your privacy before they are used. Any related information given to researchers will also be coded. Researchers will receive the code instead of any information that might directly identify you.

There can be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Even though your genes are unique, you share some of the same genes with your blood relatives.

Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that the risks to you and your family are very low, because your samples will be coded. Research results will not be returned to you or your doctor.

Very rarely health or genetic information could be misused by employers, insurance companies, and others. For example, life insurance companies may charge a higher rate based on this information.

Some states have laws to protect against genetic discrimination [list appropriate state information if your state has such laws]. A federal law called the Genetic Information Non-Discrimination Act, or GINA is in effect. This law does not allow discrimination by insurers or employers. The law does not include other types of misuse by life insurance, disability, or long term care insurance. To learn more about the GINA Law, please ask [Note to local investigator: List contact information here for patient representatives or other individuals who take calls regarding clinical trials but who are not on the site IRB or research team.]

Making Your Choice

Please read each sentence below and think about your choice. After reading each sentence, circle "Yes" or "No". If you have any questions, please talk to your doctor or nurse, or call our research review board at __________________________ [IRB's phone number].

No matter what you decide to do, it will not affect your care.

24 RTOG 1106/ACRIN 6697


5. I agree to have my blood collected to be used in a research study, as explained above.

Yes _______ No _______

6. My specimens may be kept for use in research to learn about, prevent, or treat cancer, as follows:


7. My specimens may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease), as follows:


8. Someone may contact me in the future to ask me to take part in more research. Yes No

Where can I get more information?

You may call the National Cancer Institute's Cancer Information Service at: 1-800-4-CANCER (1-800-422-6237)

You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://www.cancer.gov/cancertopics/

For more information about PET/CT scans, you can go to ACRIN's web site at http://www.acrin.org/PATIENTS/ABOUTIMAGINGEXAMSANDAGENTS/ABOUTPETSCANS.aspx. You or your doctor can print a description of PET/CT scans from this web site.

You will get a copy of this form. If you want more information about this study, ask your study doctor.

SignatureI have been given a copy of all _____ [insert total of number of pages] pages of this form. I have read it or it has been read to me. I understand the information and have had my questions answered. I agree to take part in this study.

Participant ________________________________

Date _____________________________________

25 RTOG 1106/ACRIN 6697

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