Download radiation therapy oncology group

RADIATION THERAPY ONCOLOGY GROUP
American College of Radiology Imaging Network
Informed Consent Template
for 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 FDGPET/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 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].
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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?
Before-treatment PET/CT scans
You 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 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 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:
If you are in group 1 (often called "Arm A"), you will have this imaging between weeks 4 and 5 of radiation
therapy.
If you are in group 2 (often called "Arm B"), 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.
Each radiation treatment takes about 30 minutes.
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
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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
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-treatment FDG-PET/CT and FMISO scans
Randomize
(You will be in one Group or the other)
Group 1
Standard Radiation Therapy once a day,
M-F, for 5 weeks and
Chemotherapy once a week for 6 weeks
Group 2
Individualized Radiation Therapy
once a day, M-F, for 3-4 weeks and
Chemotherapy once a week for 6 weeks
Group 1
During-treatment FDG-PET/CT scan
between weeks 4 and 5 of radiation
treatment
Group 2
During-treatment FDG-PET/CT scan
between weeks 3 and 4 of radiation
treatment
Group 1
Standard Radiation Therapy once a
day, M-F, for 1 week
(with chemotherapy)
Group 2
Adaptive Radiation Therapy based on
during-treatment FDG-PET/CT, once a
day, M-F, for 2-3 weeks
(with chemotherapy)
All patients
4-6 weeks after completion of radiation,
Chemotherapy every 21 days X 3
(total of 6 weeks)
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Before you begin the study:
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 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 with contrast: a CT scan is a
study using x-rays to look at one part of your body. Contrast 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
 An FMISO-PET/CT scan
 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
 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 pregnant
If 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:
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. They are part of regular cancer care.

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 tests
You also will have some blood tests weekly.
When you are finished treatment:
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
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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 1st year and every 6
months in the 2nd year after treatment
If your doctor recommends:
 A bronchoscopy, a test in which a hollow, flexible tube is inserted through your mouth or nose into
your airway
How long will I be in the study?
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 and 3 months after treatment, then 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?
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.
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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.
Risks and side effects related to 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.
Very Likely
 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
Less Likely, but Serious
 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
 Inflammation of the spinal cord
 A second cancer caused by the radiation you receive
Risks and side effects related to Paclitaxel and Carboplatin
Very Likely
 Low white blood cell counts, which may result infections
 Low red blood cell counts, which may result in tiredness or weakness
 Low platelet counts, which may result in bruising or bleeding
 Nausea
 Vomiting
 Loss of appetite
 Diarrhea
 Fatigue
 Hair loss
 Muscle weakness
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Joint and muscle aches
Abnormalities in blood tests
Lightheadedness
Headaches
Numbness in the hands and feet
Changes in blood pressure
Skin irritation at site of drug injection
Less Likely
 Sores in mouth and/or throat
 Alterations in taste
 Allergic reaction (including flushing, skin rash, changes in blood pressure and/or difficulty breathing)
 Stomach cramps
 Loss of blood supply to the intestines, which may require surgery
 Inflamed pancreas, which may result in pain and/or weight loss
 Dizziness and shooting back pain when bending your neck forward
 Confusion
 Blurred vision or a sensation of flashing light
 Mood changes
 Kidney damage
 Liver damage and/or failure
 Seizures
 Fainting
 Irregular heartbeat
 Heart attack
Rare
 Acute leukemia, a cancer of the bone marrow that prevents normal manufacture of red and white blood
cells
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
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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?
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.
For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute’s Web
site at http://cancer.gov/clinicaltrials/understanding/insurance-coverage. You can print a copy of the “Clinical
Trials and Insurance Coverage” information from this Web site.
Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free
copy.
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.
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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.
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.
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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.
Risks
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.
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:
 Tissue Yes  No
 Blood Yes  No
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4. 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 (1-800-4226237)
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 _____________________________________
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