Download privileged communication - Southeast Clinical Oncology Research

IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
A Phase III Randomized Trial of Imatinib, with or without Bevacizumab, in Patients
with Metastatic or Unresectable Gastrointestinal Stromal Tumors
What is a research study?
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 gastrointestinal stromal
tumor (GIST) that has spread or that cannot be removed by surgery.
Why is this study being done?
The purpose of this study is to find out whether the combination of imatinib and
bevacizumab is better than the usual treatment of imatinib alone. We currently do not
know if imatinib plus bevacizumab is better than imatinib by itself.
Imatinib is the usual treatment for GIST. Bevacizumab is a research drug. Although it
has been approved by the FDA (Food and Drug Administration) for other types of
cancer, it has not been approved for GIST.
How many people will take part in the study?
About 572 people will take part in this study.
What will happen if I take part in this research study?
Study plan
You will be "randomized" into one of the study groups described below. Randomization
means that you are put into a group by chance. Neither you nor your doctor can choose
the group you will be in. You will have an equal chance of being placed in each group.
Group 1
If you are in group 1, you will receive imatinib and bevacizumab.
Group 2
If you are in group 2, you will receive imatinib alone.
The treatment schedule for imatinib is the same for both groups. You will take 400 mg
of imatinib once every day. This could be either one 400 mg tablet or four 100 mg
tablets. If you are in the group with bevacizumab, it will be given through an IV in your
vein once every 3 weeks. The IV will take about 90 minutes at first, but may be
shortened after you receive more treatments.
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Page 1 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
Soon after you start treatment, a lab will study your tumor tissue to see if you have an
"exon 9 mutation". (You will not need to have an extra biopsy for this.) If the lab finds
that you have an exon 9 mutation, it will tell your study doctor. Then your dose of
imatinib will be increased gradually from 400 mg to 800 mg. This is because patients
who have an exon 9 mutation do better on 800 mg imatinib than they do on 400 mg
imatinib.
You should take imatinib with a meal and a large glass of water. You should take it
while sitting up and wait at least 1 hour before going to bed. If you vomit the pills, do
not try to "make up" that dose by taking more. Just take your next dose at the
scheduled time. For the entire time that you are being treated with imatinib, you should
eat low-fat breakfasts and avoid foods that contain caffeine or grapefruit.
Before you begin the study …
You may 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. These tests will be done in an outpatient setting.
 Physical exam
 Urine tests
 Blood tests for blood counts, kidney function, liver function, electrolytes, and
clotting time (about 2 teaspoons of blood will be drawn.)
 MRI or CT scans
5/11/09
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. These tests will be done in an outpatient setting.
 Physical exam: done once every 3 weeks
 MRI or CT scans: during Week 9, then every 12 weeks or 3 months
 Blood tests for blood counts: done once a week for the first 7 weeks of
treatment, and then once every 3 weeks (Less than 1 teaspoon of blood will be
drawn each time these tests are done.)
 Blood tests to measure electrolytes and kidney and liver function: done once
every 3 weeks (Less than 1 teaspoon of blood will be drawn each time these
tests are done.)
 Urine tests (for patients in Group 1 only): done once every 6 weeks, starting on
week 7 of treatment
You will need these tests and procedures that are either being tested in this study or
being done to see how the study is affecting your body.
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Page 2 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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Tissue taken before you began the study will be sent to a lab. You will not need
to have another biopsy for this. The tissue will be used to confirm your diagnosis
and to find out whether your tumor has a mutation that requires a higher dose of
imatinib. The results of this test will be given to your doctor and put in your
health records.
The tissue may also be used for research to study the biology of your cancer.
The results of the research will not be given to you or your doctor. Although the
results will not affect your treatment, the tests may help future patients. Reports
about research done with your tissue will not be put in your health records.
Results from this research may be published, but you will not be identified in
these publications
When I am finished with treatment…
You will need these tests and procedures that are part of regular cancer care. They
are being done more often because you are in this study. These tests will be done in an
outpatient setting.
 Physical exams: may be done as often as every 3 months for up to 7 years from
the time you start the study
 X-rays and/or scans: may be done as often as every 3 months for up to 7 years
from the time you start the study
 Blood tests: may be done as often as every 3 months for up to 7 years from the
time you start the study ( About 1 ½ teaspoons of blood will be drawn each time
these tests are done.)
How long will I be in the study?
You will be asked to take imatinib and bevacizumab or imatinib alone until your disease
gets worse or until side effects become too great for you. After you are finished taking
the drugs, the study doctor will ask you to visit the office for follow-up exams as
explained above. We will follow your health status for up to seven years from the time
you start the study.
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 drugs can be evaluated by your doctor. Another reason to tell your 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 end your participation 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.
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Page 3 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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, doctors don’t know all the side effects
that may happen. Some side effects may be unexpected or unforeseen. 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 taking the drugs. 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.
Group 1: Bevacizumab and imatinib
Likely:
 Pain, stiffness and/or cramps in your muscles, joints, limbs and/or bones
 Headache
 Diarrhea or constipation
 Loss of appetite
 Stomach pain
 Cough
 Fatigue
 Nosebleed
 Nausea or vomiting
 Indigestion
 High blood pressure: In most patients, blood pressure can be controlled with
routine medications. Rarely, uncontrolled hypertension may lead to damage to the
brain and other vital organ functions.
 Soreness in mouth or throat
 Decrease in the number of some white blood cells and platelets, which may lead
to an increased risk of infection, bruising or bleeding
 Rash or flaking of skin
 Swelling in the arms and legs
 Collection of fluid between the thin layers of tissue lining the lung and the wall of
the chest cavity
Less Likely:
 Sneezing, nasal stuffiness or postnasal drip
 Itching
 Fever
 Chills and shivering
 Discolored stools
 Hair loss
4/15/08
Page 4 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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Numbness or tingling in arms and legs
Swelling around eyelids or in other parts of the body like hands, feet, head, and
neck
Anxiety or depression
Dizziness
Irritation of the pancreas
Changes in skin color
Mild to moderate bleeding in the tumor, stomach, intestines, brain or other parts
of the body
Leakage of protein in the urine, which can rarely lead to damage to the kidney
Reactions associated with infusion of the bevacizumab: rash, chills, fever, and
rigor
Infection in various organs and tissues including skin, abdomen, soft tissues
around the rectum: In rare incidents, the infections can be serious and lifethreatening.
Blockage or inflammation of the bowels
Aches and pains in various body parts, including tumor sites, back, chest, and
throat
Hoarseness
Watery eyes
Changes in weight
Allergic reaction to imatinib
Decrease in the number of red blood cells, which may lead to increased fatigue
Fluid in the sac around the heart
Sweating
Severe skin and gut lining reaction that may include rash or death of tissue
Fluid collection in the abdomen
Dehydration
Gassiness
Heartburn
Irritation or sores
Changes in taste
Abnormal liver or bone enzyme levels
Abnormal level of bilirubin in the blood: Bilirubin is a bile pigment found in the
liver.
Increased level of creatinine in the blood: Creatinine is a substance normally
eliminated by the kidneys into the urine.
Decreased levels of potassium, sodium, and /or phosphates in your blood.
Arthritis
Destruction or death of bone
Abnormal changes in brain function
The abnormal buildup of cerebrospinal fluid in the brain
Weakness or loss of function caused by damage to nerves
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Page 5 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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4/24/08
Condition of the nervous system that causes numbness, tingling or burning
Swelling of the nerve in the back of the eye that is responsible for vision
Shortness of breath
Swelling around the lungs
Kidney failure
Flu-like symptoms
Rare, but Serious:
 Coughing up, spitting or vomiting blood
 Severe fluid retention or swelling
 Severe allergic reaction (anaphylaxis), which may cause difficulty breathing, hives
with itching, low blood pressure, and possibly death
 Cataract development
 Bowel tear: This occurs rarely in patients given bevacizumab, and the risk may be
more related to previous surgery or the cancer itself. Bleeding can also occur. This
can happen with bevacizumab or with imatinib, and it is possible that the two taken
together will lead to higher than expected rates of bleeding. Both bowel tear and
bleeding can be life-threatening.
 Breakdown in the surgical connection between two sections of bowel, if you have
had bowel surgery
 Possible delay or compromise of wound healing
 Bleeding from the bladder
 Liver failure possibly related to an interaction of imatinib with high doses of
acetaminophen (an active ingredient in Tylenol and Percocet): This could be severe
and possibly fatal.
 Inflammation of the lungs
 In animal studies, prolonged use of imatinib resulted in an increase in tumors of the
kidney, urinary bladder, and genital area
 Blood clots in the legs, lungs, and brain
 Reversible Posterior Leukoencephalopathy Syndrome (RPLS) or similar
leukoencephalopathy syndrome: RPLS is a medical condition related to leakiness
of blood vessels in the brain and can cause confusion, blindness or vision
changes, seizure and other symptoms, as well as changes in brain scans. This
condition is usually reversible, but in rare cases, it is potentially life-threatening
and may have long-term effects on brain function.
 Changes in blood tests that measure injury to the heart
 Abnormal heart rhythm
 Decrease in heart's ability to pump blood
 Neutropenia (decrease in white cells) and infections are known side effects of
chemotherapy drugs; the incidence of neutropenia may be increased when
bevacizumab is added to chemotherapy. In some clinical studies of bevacizumab
plus chemotherapy, there was also an increase in neutropenia-related fever and
infections, including rare incidents of infection with fatal outcome.
 Serious or fatal bleeding from the tumor, brain, gut or the lungs
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Page 6 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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Fistula formation (defect in the walls of organs such as the nose, upper airways,
lungs, esophagus, rectum, or vagina): Fistula formation may lead to lifethreatening complications including serious infections, bleeding or dysfunction of
the organs.
Stroke
Abnormal changes or scarring in the lungs that may cause difficulty breathing or
respiratory failure
Blood clots or blocking of blood vessels (including stroke, heart attack or other
conditions associated with the formation of blood clots): Patients taking
bevacizumab with chemotherapy, including imatinib, may have a higher chance
of developing blood clots as compared with those taking bevacizumab by itself.
Patients who were 65 or older, or those with past problems with blood clots in
their arteries, appeared to be at greatest risk for these problems.
Presence of gas and fluid in area around lungs
Sudden death
Group 2: Imatinib alone
Likely:
 Decrease in the number of some white blood cells and platelets, which may lead
to an increased risk of infection, bruising or bleeding
 Fatigue
 Rash or flaking of skin
 Diarrhea
 Nausea and vomiting
 Swelling in the arms and legs
 Pain in your joints and muscles
 Collection of fluid between the thin layers of tissue lining the lung and the wall of
the chest cavity
Less Likely:
 Allergic reaction
 Decrease in the number of red blood cells, which may lead to increased fatigue
 Fluid in the sac around the heart
 Fever
 Chills and shivering
 Sweating
 Weight gain
 Hair loss
 Changes in skin color
 Itching
 Severe skin and gut lining reaction that may include rash or death of tissue
 Loss of appetite
4/15/08
Page 7 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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Fluid collection in the abdomen
Constipation
Dehydration
Gassiness
Heartburn
Irritation or sores
Changes in taste
Bleeding in the brain
Bleeding from the gastrointestinal tract (for example, the stomach or intestines)
Bleeding inside the tumor
Infection
Swelling in the head and neck
Abnormal liver or bone enzyme levels
Abnormal level of bilirubin in the blood: Bilirubin is a bile pigment found in the
liver.
Increased level of creatinine in the blood: Creatinine is a substance normally
eliminated by the kidneys into the urine.
Decreased levels of potassium, sodium, and /or phosphates in your blood
Arthritis
Destruction or death of bone
Dizziness
Abnormal changes in brain function
The abnormal buildup of cerebrospinal fluid in the brain
Anxiety
Weakness or loss of function caused by damage to nerves
Condition of the nervous system that causes numbness, tingling or burning
Swelling of the nerve in the back of the eye that is responsible for vision
Watery eyes
Pain in your abdomen, back, chest, head, and throat
Cough
Shortness of breath
Swelling around the lungs
Kidney failure
Flu-like symptoms
Formation or presence of a blood clot inside a blood vessel
Rare, but Serious:
 Decrease in heart’s ability to pump blood
 Scarring of the lungs that can affect your ability to breathe and may make you
short of breath
4/15/08
Page 8 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
11/1/08
Risks related to fertility and pregnancy: The drugs in this study may affect the way a
woman’s ovaries work and her ability to get pregnant. Therefore, women should not
become pregnant and men should not father a baby while on this study and up to 6
months after you take your last dose of bevacizumab because the drugs in this study
can affect an unborn baby. You should not breastfeed a baby while on this study or up
to 6 months after you take your last dose of bevacizumab. It is important you
understand that you need to use a barrier method of birth control while on this study.
Both men and women must use a reliable method of birth control while participating in
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.
Reliable methods of birth control are considered to be: abstinence (not having sex),
tubal ligation, hysterectomy or vasectomy of the partner (with confirmed negative sperm
counts) in a monogamous relationship (same partner). An acceptable, although less
reliable method involves the careful use of condoms and spermicidal foam or gel and/or
cervical cap or sponge. Both male and female patients should ask about counseling
and more information about preventing pregnancy. Female patients who feel they might
be pregnant, even though they practiced birth control, must notify the study doctor
immediately. A pregnancy test may be performed.
Male patients should also inform the study doctor immediately if their sexual partners
become pregnant while the patient is receiving treatment. Women should not
breastfeed a baby while on this study. Pregnant women and nursing mothers are
excluded from participation in this study. If a woman becomes pregnant, she will be
withdrawn from the study. If a man fathers a child, there may be potential risk to the
unborn baby; therefore, female sexual partners of men on treatment should use an
adequate form of birth control.
Since most methods of birth control are not 100% reliable, if you are a sexually active
woman of childbearing potential, a pregnancy test (at least 10 days from your last
normal menstrual period) is required.
Please use caution when taking other medications. Common medications like Tylenol
and St. John's Wort can interact with imatinib. Grapefruit juice may have a similar
effect. Talk to your doctor if you are concerned about taking other medications.
For more information about risks and side effects, ask your study doctor.
Will I benefit from taking part in the study?
Taking part in this study may or may not make your health better. We do know that the
information from this study will help doctors learn more about the combination of
imatinib plus bevacizumab as a treatment for cancer, whether you get one drug or both.
This information could help future cancer patients.
4/15/08
Page 9 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
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: This may
include the standard treatment of imatinib alone.
 Taking part in another study
 Getting no treatment
 Getting comfort care, also called palliative care: This type of care helps reduce
pain, tiredness, appetite problems, and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to improve how you feel.
Comfort care tries to keep you as active and comfortable as possible.
Talk to your doctor about your choices before you decide if you will take part in this
study.
4/24/08
Will my medical information be kept private?
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.
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance, research, and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Southwest Oncology Group (SWOG)
The American College of Radiology Imaging Network (ACRIN)
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at ____________ Hospital
A qualified representative of Genentech, the drug manufacturer for
bevacizumab
Possible other federal or state government agencies
If your record is used or given out for governmental purposes, it will be done under
conditions that will protect your privacy to the fullest extent possible consistent with laws
relating to public disclosure of information and law-enforcement responsibilities of the
agency. These agencies may review the research to see that it is being done safely
and correctly.
You authorize the use of clinical information contained in your records, but any
publication which includes such information or data shall not reveal your name, show
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Page 10 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
your picture or contain any other personally identifying information, except as otherwise
required by law.
What are the costs of taking part in this study?
You and/or your health plan/insurance provider (Medicare should be considered a
health insurance provider) 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 or your insurance carrier will be
responsible for the costs of clinic visits, any hospital admissions, laboratory tests, xrays, scans, chemotherapy treatments, radiation treatments, and any other tests.
Please ask your doctor about any added costs or insurance problems.
Administration of bevacizumab will be charged in the usual way. The parts of the
research consisting of keeping research records will be paid by those organizing and
conducting the research. The research requires that you receive certain standard
medical tests and examinations. These standard tests and examinations will be
charged in the usual way.
The Division of Cancer Treatment and Diagnosis with the National Cancer Institute
will provide you with the research drug bevacizumab at no cost to you, if you are in
Group 1. The bevacizumab will be provided free of charge while you are participating in
this study. However, if you should need to take it much longer than is usual, it is
possible that the free supply of bevacizumab given to the NCI could run out. If this
happens, your study doctor will discuss with you how to obtain additional drug from the
manufacturer and you may be asked to pay for it.
5/11/09
Imatinib is commercially available, which means you or your insurance company will be
charged in the usual way.
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/insurancecoverage. You can print a copy of the “Clinical Trials and Insurance Coverage”
information from this Web site.
You will not be paid to participate 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, _________________________ if you feel
that you have been injured because of taking part in this study. You can tell the doctor
in person or call him/her at #____________________________.
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
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Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
medical treatment. Although no funds or monies have been set aside to compensate
you in the event of injury or illness related to the study treatment or procedures, you do
not waive any of your legal rights for compensation by signing this form.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
What are my rights if I take part in this study?
Taking part in this study is voluntary. You may choose to take part, not to take part, or
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 or result in any penalty or loss of benefits to which you are
entitled.
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
A Data Safety and Monitoring Committee (DSMC), an independent group of experts, will
be reviewing the data from this research throughout the study. The DSMC is a
committee assigned to a randomized clinical trial charged or obligated with the
responsibility of monitoring performance of the trial, safety of the participants, and
effectiveness of the treatments being tested.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study. You may be asked to sign another consent form in response to
new information.
Who can answer my questions about the study?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
___________________ Institutional Review Board (which is a group of people at the
hospital in the community where you receive treatment who review the research to
protect your rights) at # _________________ (the office of ______________________).
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Page 12 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
Please note: This section of the informed consent form is about additional
research studies that are being done with people who are taking part in the main
study. You may take part in these additional studies if you want to. You can still
be a part of the main study even if you say ‘no’ to taking part in any of these
additional studies.
You can say "yes" or "no" to each of the following studies. Please mark your choice for
each study.
Future Contact
I agree to allow my study doctor, or someone approved by my study
doctor, to contact me regarding future research involving my participation
in this study.
Yes
1.
No
PET Scans
If you agree below, you will have 2 PET scans. One will be done before you
begin treatment, and one will be done during Week 4 of treatment. During a PET
scan, you receive an injection of a radioactive substance and then lay still for
about one hour while pictures are taken of your tumor. The PET scans will be
sent to a central facility for studying.
You can still take part in the treatment even if you decide not to allow PET scans
for this special testing. Your decision will not affect your care in any way.
You will receive the results of the PET scans. However, the results of research
done with the scans will not be given to you or your doctor. Although the
research will not affect your treatment, it may help future patients. Reports about
research done with your PET scans will not be put in your health records.
Results from this research may be published, but you will not be identified in
these publications.
We will do our best to make sure that the personal information in your medical
record is 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.
Records of your progress and medical images while on the study will be kept in a
confidential form at this institution and in computers at the American College of
Radiology Imaging Network (ACRIN) in Philadelphia, PA and the National
Cancer Institute in Bethesda, MD. This information will be used only for research
purposes and personal identifying information will be taken off to maintain
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Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
confidentiality. Research studies may be conducted on aspects of the data
collected during the study. At this time it is not known what type of studies may
be conducted. Some possibilities might affect patient care or future studies of a
medical or non-medical nature.
Organizations that may look at and/or copy your medical data for research,
quality assurance, and data analysis include: The National Cancer Institute (NCI)
and other government agencies, like the Food and Drug Administration (FDA),
involved in keeping research safe for people; a Data Safety and Monitoring
Board; the University of Washington and other researchers who have a role in
this study, but your name, and any other information that identify you personally
will not be included.
4/24/08
The cost of the PET scans will be covered either by Medicare, by your insurance
or by the study sponsor (up to a set amount). Please discuss with the study
doctor what the potential additional costs could be.
5/11/09
I agree to participate in this additional study of PET scans.
(please circle one)
2.
YES
NO
Additional biopsies to collect fresh tissue for research
If you agree, you will have 1 - 2 additional biopsies so that fresh tissue can be
sent to the lab for testing. One biopsy might be needed before you begin
treatment (if your fresh or frozen tumor tissue is not already available) and
another might be needed if your disease becomes worse.
The purpose of the tissue testing is to study KIT and PDGFRA, and to try to find
out why some people’s cancer does not benefit from treatment. KIT and
PDGFRA are proteins made by the tumor. Different levels or types of proteins
may relate to the chance of benefit from treatment.
You can still take part in the treatment even if you decide not to allow your tissue
to be collected for this special testing. Your decision will not affect your care in
any way. The results of the testing on your tumor will not be given to you or your
doctor. Although the results will not affect your treatment, the tests may help
future patients. Reports about research done with your samples will not be put in
your health records. Results from these tests may be published, but you will not
be identified in these publications.
The cost of the pre-treatment biopsy will be covered either by your insurance or
by the study sponsors, up to a set amount. The cost of the second biopsy will be
covered by the study sponsors, up to a set amount. Please discuss with the
study doctor what the potential additional costs could be.
4/15/08
Page 14 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
I agree to participate in this additional study of fresh tissue.
5/11/09
(please circle one)
5/11/09
3.
YES
NO
Blood draws
If you agree, some of your blood will be sent to a lab to study the biology of your
cancer. You will have four blood draws for this purpose. These will take place
before you begin treatment, after 9 weeks, after 21 weeks, and when your
disease gets worse. Between 3-5 teaspoons of blood will be drawn at each of
these times. The results of the testing on your blood will not be given to you or
your doctor. Although the results will not affect your treatment, the tests may
help future patients. Reports about testing done with your blood will not be put in
your health records. Results from these tests may be published, but you will not
be identified in these publications. Any blood left over after testing will be
destroyed.
I agree to participate in this study of blood.
(please circle one)
4.
YES
NO
Storing Tissue for Future, Unspecified Testing
You have had a biopsy to see if you have cancer. Your doctor has removed
some body tissue to do some tests. The results of these tests have been given to
you by your doctor and will be used to plan your care.
As described above, some of this tissue will be sent to a lab to confirm your
diagnosis and to study the biology of your cancer. 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 "How is Tissue Used for
Research" to learn more about tissue research.
The research that may be done with your tissue 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 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 leftover tissue for future research is up to you. No
matter what you decide to do, it will not affect your care.
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Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
If you decide now that your tissue 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. Then any tissue that remains will no longer be used for research.
In the future, people who do research may need to know more about your health.
While the Southwest Oncology Group 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 is used for genetic research (about diseases that are passed
on in families). Even if your tissue is used for this kind of research, the results will
not be put in your health records.
Your tissue will be used only for research and will not be sold. The research done
with your tissue may help to develop new products in the future.
Benefits
The benefits of research using tissue 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 #________________.
No matter what you decide to do, it will not affect your care.
1.
My tissue may be kept for use in research to learn about, prevent,
treat or cure cancer.
Yes
No
2.
My tissue may be kept for use in research about other health
problems (for example: diabetes, Alzheimer's disease or heart
disease).
Yes
3.
Someone may contact me in the future to ask me to allow other uses
of my tissue.
Yes
4/15/08
No
Page 16 of 20
No
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Consent Form
If you decide to withdraw your tissue from a Southwest Oncology Group
Specimen Repository in the future, a written withdrawal of consent should be
submitted through your treating doctor to the Southwest Oncology Group
Operations Office. Please designate in the written withdrawal whether you would
prefer to have the tissue destroyed or returned to the treating doctor.
Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615
 You may also visit the NCI Web site at http://cancer.gov
 For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials
 For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo
Participant Agreement
I have been offered the opportunity to ask questions about this study and all questions
have been answered to my satisfaction. The contents of this form have been explained
to me and I understand them. I agree to allow the research personnel specified above
the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; therefore I agree to notify my doctor of any
change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research
study. I will be given a copy of all 20 pages of this consent. I have read it or it has been
read to me. I may also request a copy of the study (complete study plan).
______________
(Date)
_________________________________
(Participant Signature)
I certify that I have explained to the above individual the nature and purpose, the
potential benefits, and possible risks associated with participation in the research study
and have answered any questions that have been raised.
______________
(Date)
4/15/08
_________________________________
(Signature of Person Obtaining Consent)
Page 17 of 20
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Information Sheet
Tissue Consent Supplemental Sheet
How is Tissue Used for Research?
Where does tissue come from?
After a person has had a biopsy (or surgery) and all tests have been done, there may
be some leftover tissue. Sometimes, this tissue is thrown away because it is not
needed for the patient's care. Instead, a patient can choose to have the tissue kept for
future research. People who are trained to handle tissue and protect donors' rights
make sure that the highest standards of quality control are followed by the Southwest
Oncology Group. Your doctor does not work for the Southwest Oncology Group, but
has agreed to help collect tissue from many patients. Many doctors across the country
are helping in the same way. If you agree, only leftover tissue will be saved for
research. Your doctor will not take more tissue during surgery than needed for your
care.
Why do people do research with tissue?
Research with tissue can help to find out more about what causes cancer, how to
prevent it, how to treat it, and how to cure it. Research using tissue can also answer
other health questions. Some of these include finding the causes of diabetes and heart
disease, or finding genetic links to Alzheimer's disease.
What type of research will be done with my tissue?
Many different kinds of studies use tissue. Some researchers may develop new tests to
find diseases. Others may develop new ways to treat or even cure diseases. In the
future, some of the research may help to develop new products, such as tests and
drugs. Some research looks at diseases that are passed on in families (called genetic
research). Research done with your tissue may look for genetic causes and signs of
disease.
How do researchers get the tissue?
Researchers from universities, hospitals, and other health organizations conduct
research using tissue. They contact the Southwest Oncology Group and request
samples for their studies. The Southwest Oncology Group reviews the way that these
studies will be done, and decides if any of the samples can be used. The Southwest
Oncology Group gets the tissue and information about you from your hospital, and
sends the tissue samples and some information about you to the researcher. The
Southwest Oncology Group will not send your name, address, phone number, social
security number or any other identifying information to the researcher.
Will I find out the results of the research using my tissue?
You will receive the results of your biopsy, but you will not receive the results of
research done with your tissue. This is because research can take a long time and
must use tissue samples from many people before results are known. Results from
4/15/08
Page 18 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Information Sheet
research using your tissue may not be ready for many years and will not affect your
care right now, but they may be helpful to people like you in the future.
Why do you need information from my health records?
In order to do research with your tissue, researchers may need to know some things
about you. (For example: Are you male or female? What is your race or ethnic group?
How old are you? Have you ever smoked?) This helps researchers answer questions
about diseases. The information that will be given to the researcher may include your
age, sex, race, diagnosis, treatments, and family history. This information is collected
by your hospital from your health record and sent to the Southwest Oncology Group. If
more information is needed, the Southwest Oncology Group will send it to the
researcher.
Will my name be attached to the records that are given to the researcher?
No. Your name, address, phone number, and anything else that could identify you will
be removed before they go the researcher. The researcher will not know who you are.
How could the records be used in ways that might be harmful to me?
Sometimes, health records have been used against patients and their families. For
example, insurance companies may deny a patient insurance or employers may not hire
someone with a certain illness (such as AIDS or cancer). The results of genetic
research may not apply only to you, but to your family members too. For disease
caused by gene changes, the information in one person's health record could be used
against family members.
How am I protected?
The Southwest Oncology Group is in charge of making sure that information about you
is kept private. The Southwest Oncology Group will take careful steps to prevent
misuse of records. Your name, address, phone number, and any other identifying
information will be taken off anything associated with your tissue before it is given to the
researcher. This would make it very difficult for any research results to be linked to you
or your family. Also, people outside the research process will not have access to results
about any one person which will help to protect your privacy.
Where will my tissue be stored?
Your tissue will be stored at the following location:
4/24/08
Solid Tumor Specimen Repository
University of Colorado HSC at Fitzsimons
Department of Pathology
RC-1 South, Room L18-5400A
12801 East 17th Avenue
Aurora, CO 80045
Phone: 303/724-3086
4/15/08
Page 19 of 20
Participant Initials _____
IRB Approval _______________
Version: Revision #2; 5/11/09
SWOG S0502
Southeast Cancer Control Consortium Information Sheet
What if I have more questions?
If you have any questions, please talk to your doctor or nurse, or call our research
review board at #_____________________.
4/15/08
Page 20 of 20
Participant Initials _____
SWOG S0502
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
4/15/08
SWOG S0502
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Participant Name ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
4/15/08