Download Randomized Phase III Trial Comparing Two Different Rituximab

IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens
for Low Tumor Burden Patients with Indolent non-Hodgkin’s Lymphoma
What is a research study?
You are being asked to take part in this study because you have non-Hodgkin’s
lymphoma.
This is a clinical trial (a type of research study). Clinical trials include only patients who
choose to take part. Please take your time to make your decision and discuss it with
your friends and family.
4/17/08
Why is this study being done?
The purpose of this study is to establish whether single doses of rituximab given at 13week intervals can prolong disease control compared to giving rituximab once a week
for four consecutive weeks at time of disease progression.
This study includes a laboratory study that will mathematically relate the rituximab levels
in your blood to your response to rituximab. Although this study is very important to
understanding how rituximab affects your lymphoma, you do not have to be in the
laboratory study to participate in the treatment study.
5/30/07
How many people will take part in the study?
About 519 people will take part in this study nationally.
What is involved in this study?
Please see the Study Plan on the next page.
(This space was left blank intentionally).
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Page 1 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
STUDY PLAN
REGISTRATION
INITIAL RITUXIMAB
You will receive 375 mg/m2 of rituximab into a vein once a week for 4 weeks. This will take
4-8 hours the first time, but may take less time (3-6 hours per dose) after that.
RESTAGING VISIT
tests will be done to see if the initial rituximab worked
against your lymphoma
If no response (if your
lymphoma did not get
better at all), you will end
the study treatment.
Your doctor will discuss
other treatment options
with you.
RANDOMIZATION
If the initial rituximab worked against your lymphoma, you will
be assigned at random (you and your doctor will not choose)
to one of the two treatment arms
(4/17/08) Group A
rituximab retreatment dosing
(4/17/08) Group B
rituximab scheduled dosing
You will receive rituximab by vein
(375 mg/m2) once a week for 4
weeks every time your lymphoma
gets worse, unless it gets worse less
than 26 weeks from your last
treatment, your lymphoma does not
get better after treatment, or you
choose to stop being treated.
(4/17/08)
You will receive one dose of
rituximab by vein (375 mg/m2) every
13 weeks until your disease gets
worse or you choose to stop being
treated. (4/17/08)
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Page 2 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
The study involves treatment with the monoclonal antibody rituximab (also called
Rituxan). A monoclonal antibody is a laboratory-produced protein that reacts with a
very specific antigen (protein) found on lymphoma cells. Rituximab has been approved
by the Food and Drug Administration (FDA) for use in the treatment of relapsed
lymphoma (lymphoma which got worse after it had been getting better or seemed to be
gone).
4/17/08
You will receive rituximab intravenously (into a vein). The first time the drug is
given it may take 4-8 hours. It may only take 3-6 hours to receive the remaining doses.
You will be given the rituximab once a week for four weeks as an outpatient.
About 9 weeks after your last dose of rituximab, your condition will be checked again.
If your disease got better following the rituximab therapy, you will be randomized to one
of two possible types of treatment, called “groups or arms”: rituximab retreatment dosing
“Group A”, or rituximab scheduled dosing “Group B”. Randomization means you are put
into a treatment arm by chance (similar to a flip of a coin). You will have an equal
chance of being placed into either arm. You and your doctor will not be able to choose
which dosing regimen you receive. If your disease stayed the same or got worse after
the initial rituximab treatment, you will stop protocol treatment, and your doctor will
discuss other treatment options with you.
4/17/08
4/17/08
4/17/08
4/17/08
4/17/08
4/17/08
4/17/08
4/17/08
5/30/07
Group A
If you are assigned to Group A, you will be observed without any additional treatment
unless your disease gets worse. This is the standard way to give rituximab. If your
response to rituximab lasts longer than 26 weeks, you may be retreated with rituximab
when and if your disease gets worse. If your disease stays the same after this
retreatment, or gets worse in less than 26 weeks, you will end the protocol treatment
and your doctor will discuss other treatment options with you.
If your disease responds to the retreatment with rituximab (gets better), you will again
receive rituximab retreatment when and if your disease gets worse, as long as your
lymphoma is better for at least 26 weeks. If at any time your disease gets worse
in less than 26 weeks from your most recent rituximab treatment, you will be taken off
study treatment and your doctor will discuss other treatment options with you.
Group B
If you are assigned to Group B, you will receive a single dose of rituximab every 13 weeks
as long as your disease does not get worse. If your disease gets worse you will be taken
off study treatment, and your doctor will discuss other treatment options with you.
Your doctor will stop this treatment if your cancer grows or if your side effects are
severe. You may choose to stop treatment at any time. Your doctor will also stop this
treatment if new scientific information shows this treatment is not best for you or if your
10/03
Page 3 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
doctor feels it is not in your best interest to continue it. He or she will discuss other
treatments with you.
4/17/08
4/17/08
4/17/08
5/27/05
5/27/05
What other procedures or tests are needed?
Before beginning treatment you will have a physical exam, blood tests, a pregnancy test
if you are a female of childbearing potential, bone marrow biopsy and CT scans (type of
x-ray using computers) of the neck, chest, abdomen, and pelvis. While you are on
study, you will have blood drawn every 13 weeks for tests. After you have completed
the initial treatment with rituximab, you will have CT scans of the neck, chest, abdomen,
and pelvis to assess your disease. You will then have a physical exam and blood drawn
for tests every 13 weeks. You will have CT scans of the neck, chest, abdomen, and
pelvis every 26 weeks.
You may have a bone marrow biopsy before you begin treatment. Your doctor may
want to repeat the bone marrow biopsy at some point during the study to confirm your
response to treatment. A bone marrow biopsy is a procedure that you may have had
before. It requires the removal of a small piece of bone by a special needle, which is
usually inserted in the back of the pelvis. As part of the same procedure, a bone
marrow aspiration may be performed, which means that blood will be drawn out of the
middle of the bone to examine cells there (in the bone marrow). This procedure is
usually done under local anesthesia. Complications can include pain and bleeding.
5/05,4/08
After you have completed the initial treatment with rituximab and it has been determined
that you will be randomized, you will also be asked to complete a questionnaire to
evaluate how your lymphoma is affecting your quality of life. The questionnaire is
expected to take less than 15 minutes to complete, and your study nurse or doctor will
be available to help with any questions you may have.
4/17/08
You will be asked to complete the same questionnaire at 26, 39, 65, 117, 169 and 221
weeks after you have been randomized to either Group A or Group B and when you
stop treatment.
Central Review:
While you are on study, samples of your tissue, blood, or bone marrow will be sent to a
central laboratory to be examined by a central reviewer. This review is to confirm the
results of the local laboratory review.
5/30/07
Optional Laboratory Studies:
As noted earlier, this clinical trial includes a study which examines rituximab levels in
your blood as they relate to your response to rituximab. Although this study is very
important, you do not have to be in the laboratory study to participate in the treatment
study. If you do choose to participate in the laboratory study you will have the following
procedures:
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Page 4 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
Differences in the way the body handles drugs such as rituximab may explain why some
people respond to a treatment and others do not. While you are on this study, we would
like to monitor the levels of rituximab in your blood. About 1 teaspoon of blood would be
collected 4-5 times during the study and once later if you relapse (if your lymphoma
comes back). This blood would be collected when the samples for monitoring your
health are drawn. No additional sticks would be necessary.
The blood will be sent to a central tissue repository until it is sent to a central laboratory
for analysis. The results of the tests will not be sent back to your doctor and they will
not be used to determine your care.
How long will I be in the study?
You will be in the study until:
 Rituximab is no longer effective in controlling your disease;
 Your doctor decides your disease needs to be managed with different therapy
 You decide to discontinue participation
 If new scientific information shows this treatment is not best for your disease, or if
your doctor feels it is no longer in your best interest to continue
We would like to keep track of your medical condition for 15 years from the time you
enter the study.
You may stop participating at any time. Your decision will not affect your care at this
institution now or later. However, if you decide to stop participating in the study, we
encourage you to talk to your doctor first. You may be asked to come to the clinic for a
final exam and blood draw. For purposes of research, we may continue to collect clinical
data from your medical records after you stop study treatment unless you request
otherwise.
6/18/10
What are the risks of the study?
While on the study, you are at risk for side effects. The rituximab may cause some, all
or none of the side effects listed. You should discuss these with your doctor first. There
may also be other side effects that we cannot predict. Other drugs will be given to make
side effects less serious and less uncomfortable. Many side effects go away shortly
after the rituximab is stopped, but in some cases side effects can be serious, long
lasting, permanent or life threatening. Death from the drug is rare, but possible.
6/18/10
Your doctor will check you closely to see if any of the side effects are occurring and
routine blood tests will be done to monitor the effects of treatment.
The most common risk with rituximab is an infusion reaction. This is most likely to occur
within a few hours of the first infusion and does not typically occur with subsequent
infusions.
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Page 5 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
Likely: (Updated 5/30/07 and 6/18/10)
 Chills
 Fever
 Reaction that can occur during or following infusion of the drug. The reaction
may include fever, chills, rash, low blood pressure, and difficulty breathing.
 Decreased number of a type of white blood cell (lymphocyte)
Less Likely: (Updated 5/30/07 and 6/18/10)
 Lack of enough red blood cells (also called anemia)
 Thickening of blood/serum as found in Waldenstrom's macroglobulinemia (a
cancer of certain blood cells)
 Fever associated with dangerously low levels of a type of white blood cell
(neutrophils)
 Heart attack caused by a blockage of a blood vessel supplying part of the heart
 Fast heartbeat with a regular rhythm
 Fast heartbeat usually originating in an area located above the ventricles
 Belly pain
 Diarrhea
 Nausea or the urge to vomit
 Vomiting
 Swelling of the arms and/or legs
 Fatigue or tiredness
 Pain
 Allergic reaction by your body to the drug product that can occur immediately or
may be delayed. The reaction may include hives, low blood pressure, wheezing,
swelling of the throat, and difficulty breathing.
 Allergic reaction to certain medications, injected proteins, or antisera (blood
product) used to treat certain medical conditions (such as an infectious or
poisonous substance)
 Infection
 Awakening of viruses which have been latent/dormant
 Infection in HIV positive patients
 Decreased number of a type of white blood cell (neutrophil or granulocyte)
 Decreased number of a type of blood cell that help to clot blood (platelet)
 Decrease in the total number of white blood cells (leukocytes)
 Increased blood sugar level
 Decreased blood level of calcium
 Decreased blood level of potassium
 Joint pain
 Back pain
 Muscle pain
 Pain in the area of the tumor
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Page 6 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
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Dizziness or sensation of lightheadedness, unsteadiness or giddiness
Headache or head pain
Abnormal drowsiness or sluggishness and an unusual lack of energy
Convulsion or seizure
Sudden or traumatic injury to the kidney
Stuffy or runny nose and sneezing
Sudden constriction of the small airways of the lung that can cause wheezing
and shortness of breath
Cough
Shortness of breath
Decrease in the oxygen supply to a tissue
Inflammation of the lungs that may cause difficulty breathing and can be lifethreatening
Sore throat
Excess sweating
Itching
Skin rash with the presence of macules (flat discolored area) and papules (raised
bump)
Swelling of body tissue underneath the skin
Hives
Sudden reddening of the face and/or neck
High blood pressure
Low blood pressure
Rare, but Serious: (Updated 5/30/07 and 6/18/10)
 Serious, life-threatening allergic reaction requiring immediate medical treatment
by your doctor. The reaction may include extremely low blood pressure, swelling
of the throat, difficulty breathing, and loss of consciousness.
 Group of signs and symptoms due to rapid breakdown of tumor that can occur
after treatment of cancer has started that causes increased levels of blood
potassium, uric acid, and phosphate, decreased levels of blood calcium, and
kidney failure
 Disease affecting brain tissue, caused by a virus (specifically the JC virus: Jacob
Cruetzfeld virus)
 Severe potentially life-threatening damage to the lungs which can lead to fluid in
the lungs
 Severe reaction of the skin and gut lining that may include rash and shedding or
death of tissue
 Potentially life-threatening condition affecting less than 10% of the skin in which
cell death causes the epidermis (outer layer) to separate from the dermis (middle
layer)
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Page 7 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form

Life-threatening condition affecting greater than 30% of the skin in which cell
death causes the epidermis (outer layer) to separate from the dermis (middle
layer)
Immunization:
The safety of immunization with any vaccine, particularly live viral vaccines, following
rituximab therapy has not been studied. It is recommended that you consult with your
doctor before receiving immunizations following rituximab therapy.
Rituximab is a monoclonal antibody that is part mouse and part human (chimeric). Since
it is a foreign protein, individuals who receive rituximab may produce new antibodies
against it. These new antibodies are made by the immune system and are called either
human anti-mouse antibodies (HAMA) or human anti-chimeric antibodies (HACA). To
date this has been seen in less than 1% of patients. However, patients who develop
HAMA/HACA antibodies may have allergic or hypersensitivity reactions when treated
with rituximab or other mouse-based antibody products.
Some of the procedures required by the study pose additional risks. Risks associated
with bone marrow biopsies and aspirations and blood drawings include minor infections,
bleeding, and discomfort at the sites.
5/07,6/10
5/30/07
Reproductive Risks (Pregnancy/Birth Control):
Due to the unknown risks and potential harm to the unborn fetus, sexually active women
of childbearing potential and men who could father a baby must use a reliable method
of birth control while participating in this study. Reliable methods of birth control are
considered to be: abstinence (not having sex), oral contraceptives, Intrauterine Device
(IUD), tubal ligation 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. We encourage you to discuss this issue further with your doctors if you
have any questions. Also, because the risk to young children is unknown,
you should not nurse your baby while on this study. Ask about birth control counseling
and more information about preventing pregnancy.
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. Male patients
should also inform the study doctor immediately if their sexual partners become
pregnant while the patient is receiving treatment.
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.
10/03
Page 8 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
5/27/05
Emotional Risks:
Completing the questionnaires which are part of this study may remind you of
unpleasant aspects of your condition and treatment which may be upsetting.
Will I benefit from taking part in the study?
If you agree to take part in this study, there may or may not be direct medical benefits to
you. It is not possible to predict whether this treatment will have any benefit to you.
Possible benefits are remission (disappearance) of the tumor and prolonged survival;
however we cannot guarantee this. The possible benefits of taking part in this study are
the same as receiving rituximab without being in the study. We hope the information
learned from this study will benefit other patients with non-Hodgkin’s Lymphoma in the
future.
5/30/07
What other choices do I have if I do not take part in the study?
You have other options instead of being in this study. Alternative treatments you can
consider include:
 Treatment with standard chemotherapy or other research programs
 No therapy at this time with care to help you feel more comfortable
 You may receive rituximab at this medical center and at other medical centers,
even if you do not take part in this study
Please talk to your doctor about these and other options.
5/30/07
Will my medical information be kept private?
This study is being conducted by the Eastern Cooperative Oncology Group (ECOG).
ECOG is a cancer group that conducts studies for the National Cancer Institute. Your
doctor is a member of ECOG or of another group that is participating in this study. To
help protect your privacy, ECOG has obtained a Certificate of Confidentiality Certificate
from the U.S. Department of Health and Human Services (DHHS).
With this certificate, ECOG cannot be forced (for example, by a court subpoena) to
disclose information that may identify you in any federal, state or local civil, criminal,
administrative, legislative or other proceeding. Disclosure will be necessary, however,
upon request of DHHS for auditing or to evaluate the study.
You should understand that a Certificate of Confidentiality does not prevent you or a
member of your family from voluntarily releasing information about you or your
involvement in this research. Note, however, that if an insurer or employer learns about
your participation and obtains your consent to receive research information, then ECOG
may not use the Certificate of Confidentiality to withhold this information. This means
that you and your family must also actively protect your privacy.
Finally, you should understand that your doctor and ECOG are not prevented from
taking steps, including reporting to authorities, to prevent serious harm to yourself or
10/03
Page 9 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
others and the Certificate of Confidentiality does not prevent the review of your research
records under some circumstances by certain organizations for an internal program
audit or evaluation.
Efforts will be made to keep your personal information confidential. We cannot
guarantee absolute confidentiality. Your personal information may be disclosed if
required by law.
5/30/07
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 and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Cancer Trials Support Unit (CTSU) – a research group sponsored by the
National Cancer Institute (NCI) to provide greater access to cancer trials
Eastern Cooperative Oncology Group (ECOG) and associated central
laboratories and reviewers
Food and Drug Administration (FDA) and its representatives
Institutional Review Board (IRB) at your hospital
National Cancer Institute (NCI)
Office for Human Research Protections (OHRP)
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
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?
Taking part in this study may lead to added costs to you or your insurance company.
You or your insurance carrier will be responsible for the costs of clinic visits, any
hospital admissions, laboratory tests, x-rays, scans, chemotherapy treatments, and any
other tests. Please ask your doctor about any added costs or insurance problems. You
may find a National Cancer Institute Guide: “Clinical Trials and Insurance Coverage – a
Resource Guide” helpful in this regard. You may ask your doctor for a copy, or it is
available on the world wide web at http://www.nci.nih.gov/ClinicalTrials/insurance (click
on printable version).
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Page 10 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
In the case of injury or illness resulting from this study, emergency medical treatment is
available but will be provided at the usual charge. No funds or monies have been set
aside to compensate you in the event of injury.
You or your insurance company will be charged for continuing medical care and/or
hospitalization. You or your insurance company will not be charged for the central
reviews or the additional laboratory study that are outlined in this trial.
You will not be paid to participate in this study.
5/30/07
5/30/07
What are my rights as a participant?
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 Board, an independent group of experts, will be reviewing
the data from this research throughout the study. We will tell you about new information
that may affect your health, welfare or willingness to stay in this study.
5/30/07
5/30/07
5/30/07
Who can answer my questions about the study?
For questions about the study or a study-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 study 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 #
______________________
10/03
Page 11 of 16
Participant Initials _____
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
5/30/07
Where can I get more information?
You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-4226237) or TTY: 1-800-332-8615 or you may visit the Cancer Information Service
Website: http://www.cancer.gov/cis
You may visit the NCI’s Web site:
http://www.cancer.gov/clinical_trials
This website contains comprehensive clinical trials information and accurate cancer
information.
http://www.cancer.gov/cancer_information
This website contains accurate cancer information including PDQ.
4/17/08
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.
5/30/07
My signature below means that I have voluntarily agreed to participate in this
research study. I will be given a copy of all 16 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)
10/03
_________________________________
(Signature of Person Obtaining Consent)
Page 12 of 16
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
Additional Studies
Differences in the way the body handles drugs such as rituximab may explain why some
people respond to a treatment and others do not. While you are on this study, we would
like to monitor the levels of rituximab in your blood. About 1 teaspoon of blood should
be collected 4-5 times during the study and again if you relapse. This blood would be
collected when the samples for monitoring your health are drawn. No additional sticks
should be necessary.
The blood will be sent to a central tissue repository until it is sent to a central laboratory
for analysis. The results of the tests will not be sent back to your doctor and they will
not be used to determine your care. You or your insurance company will NOT be
charged for these tests. These tests are only for research purposes.
Making Your Choice
Please read the sentence below and think about your choice. After reading the
sentence, circle "Yes" or "No." No matter what you decide to do, it will not affect your
care. You can participate in the treatment part of the study without participating in the
research studies. If you have any questions, please talk to your doctor or nurse, or call
our research review board at #________________.
1. I agree to participate in the scientific laboratory tests that are being done as a
part of this study.
Yes
No
Please print and sign your name here after you circle your answer.
Your Name:
Your Signature:
10/03
Date:
Page 13 of 16
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
Will any of the Samples (e.g., Tissue) Taken from Me Be Used for Other Research
Studies?
About Using Tissue for Research
As a part of the clinical trial, samples of your biopsies and blood will be sent to central
laboratories and reviewers to analyze and confirm the local reviews. If you participate in
the laboratory study associated with this protocol, some of your blood will be sent to a
central laboratory for analysis.
We would like to keep some of the biopsy material and blood that is leftover for future
research. If you agree, the biopsy material and blood will be kept and may be used in
research to learn more about cancer and other diseases. Biopsy material and blood will
be given only to researchers approved by the Eastern Cooperative Oncology Group
(ECOG). Any research done on the tissue also must be approved by the researcher’s
Institutional Review Board.
Your biopsy material and blood may be helpful for research. The research that may be
done with biopsy material and blood will probably not help you. It might help people who
have cancer and other diseases in the future.
Reports about the research done with biopsy material and blood will not be given to you
or to your doctor. These reports will not be put into your health record. The research will
not have an effect on your care.
Where will my specimens be kept?
ECOG Pathology Coordinating Office
Robert E. Lurie Comprehensive Cancer Center
Northwestern University
Olson Pavilion – Room 8501
710 North Fairbanks Court
Chicago, IL 60611
Things to Think About
The choice to let us keep the leftover biopsy material and blood for future research is up
to you. No matter what you decide to do, it will not affect your care, and you may still
take part in the Eastern Cooperative Oncology Group study.
If you decide now that your biopsy material and blood can be kept for research, you can
change your mind at any time. Just contact your study doctor and let him
or her know that you do not want us to use biopsy material and blood. Then the biopsy
material and blood will no longer be used for research.
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Page 14 of 16
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
In the future, people who do research may need to know more about your health. When
the Eastern Cooperative Oncology Group gives them reports about your health, it will
not give them your name or other personal data.
Sometimes biopsy material and blood is used for genetic research (about disease that
are passed on in families). Even if your biopsy material and blood is used for this kind of
research, the results will not be put into your health records.
Your biopsy material and blood will be used only for research, and it will not be sold.
You will not be paid for allowing your leftover biopsy material and blood to be used in
research, even though the research done with your biopsy material and blood may help
to develop new products in the future. Similarly, there will be no cost to you for any
biopsy material and blood collected and stored by the Eastern Cooperative Oncology
Group.
It is possible that, at some time in the future, as part of deciding on which therapy to
give you, a new test might become available that could be done on some of the biopsy
material and blood that is now thought of as “leftover.” This situation is unusual, but it
could happen. In order to see that not all of this leftover biopsy material and blood is
used up, the Eastern Cooperative Oncology Group will take care to see that some of
your cancer biopsy material and blood is stored for 10 years so it is available if you or
your doctors should need it.
This will depend upon the amount of leftover biopsy material and blood that is submitted
for this study. However, there may not be any leftover biopsy material and blood store.
Benefits
The benefits of research using biopsy material and blood include learning more about
what causes cancer and other diseases, how to prevent them, how to treat them, and
how to cure them.
Risks
There are very few risks to you. The greatest risk is the release of information from your
health records. The Eastern Cooperative Oncology Group will protect your records so
that your name 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.” No matter what you decide to do, it will not affect your
care. You can participate in the treatment part of the study without participating in all or
part of the biopsy material and blood research studies. If you have any questions,
please talk to your doctor or nurse or call our Institutional Review Board at
____________________________________.
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Page 15 of 16
IRB Approval Date ________
Version: 5/28/10; Addendum #7
Broadcast: 6/18/10
Appendix I
CTSU/ECOG E4402
Southeast Cancer Control Consortium Consent Form
My biopsy material and blood may be kept for use in research to learn
about, prevent, treat, or cure cancer.
Yes No
My biopsy material and blood may be kept for use in research about
other health problems (for example, causes of diabetes, Alzheimer’s
disease, and heart disease).
Yes No
My doctor (or someone from the Eastern Cooperative Oncology Group)
may contact me in the future to ask me to take part in more research.
Yes
No
Please print and sign your name here after you circle your answers.
Your Name: __________________________________________
Your Signature:
10/03
__________________________________ Date:_______
Page 16 of 16
CTSU/ECOG E4402
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.
Patient Name _________________________________ Study/ID #___________
(Please Print Name)
Patient Signature _________________________________ Date ___________
Witness Signature _________________________________ Date ___________
10/03
CTSU/ECOG E4402
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.
Patient Name ________________________________Study/ID #____________
(Please Print Name)
Patient Signature __________________________________
Date __________
Witness Signature _________________________________
Date __________
10/03