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ANZGOG 0902/GOG-0274/RTOG 1174
Informed Consent
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GYNECOLOGIC ONCOLOGY GROUP
RADIATION THERAPY ONCOLOGY GROUP
SUGGESTED PATIENT INFORMATION/INFORMED CONSENT
TITLE OF RESEARCH PROJECT: A PHASE III TRIAL OF ADJUVANT
CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED
CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK
TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) NCI version March 21, 2013
PRINCIPAL INVESTIGATOR:
GENERAL
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 have also been told that you have the option not to
participate. 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.
This study is being carried out under the sponsorship of the Gynecologic Oncology Group
(GOG), an organization dedicated to clinical research in the field of gynecologic cancer and the
Radiation Therapy Oncology Group (RTOG). Both the GOG and RTOG are funded by the
Federal Government through the National Cancer Institute (NCI).
The clinical components of the trial including participation from member institutions from the
GOG and RTOG will be managed and coordinated by the Australia New Zealand
Gynaecological Oncology Group (ANZGOG). Specimen banking and tissue research from GOG
member institutions will be managed and coordinated by the GOG, and specifically the GOG
Tissue Bank. Specimen banking and tissue research from RTOG member institutions will be
managed and coordinated by the RTOG Biospecimen Resource.
You are being asked to take part in this study because you have been diagnosed with cervical
cancer which is locally advanced and not suitable for surgery. The alternative to treatment on
this trial is to receive standard cisplatin chemotherapy given at the same time as radiation.
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to compare standard treatment, radiation therapy combined with the
chemotherapy drug cisplatin (chemo-radiation), to standard chemo-radiation therapy plus
additional experimental chemotherapy with FDA approved agents carboplatin and paclitaxel to
see if it reduces the risk of tumor recurrence and improves overall survival.
Studies among patients with other cancer types have shown that the addition of more
chemotherapy after chemo-radiation reduces the risk of tumor recurrence at other places in
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the body. This has not yet been clearly established for cervical cancer patients. Giving
additional chemotherapy after initial standard treatment is known as ‘adjuvant
chemotherapy’.
The objectives of this trial are to find out whether adjuvant chemotherapy (using two other
drugs) after chemo-radiation will increase the chances of survival and reduce the risk of
tumor recurrence in the pelvis and other places. The risk and severity of side effects and
quality of life during and after treatment will also be evaluated and compared. This trial
will help the researchers understand the safety and effectiveness of this new treatment
regimen for cervical cancer.
In this trial one group will receive standard chemo-radiation alone, whereas the other group
will receive standard chemo-radiation and then additional chemotherapy.
Another purpose of this study is to test samples of your tumor tissue (if available from a previous
surgery or biopsy) and your blood to find out if any of these tests can be used in the future to
determine which patients may respond to treatment, have a good prognosis, or have side effects.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
A total of 780 women will participate in this study internationally. Both the GOG and RTOG
anticipate enrolling approximately half of these patients.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
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.
 History and physical examination which will include a pelvic examination
 Height and weight measurements
 Blood tests to measure blood counts, blood mineral levels, and check liver and
kidney function
 A pregnancy test if you are capable of becoming pregnant
 CT scan of the chest, abdomen and pelvis
 An MRI of the pelvis and/or PET scan of your entire body are optional studies
which will be offered to you as part of your pre-treatment evaluation
 Review of medications and supplements you are currently taking
You will undergo the following procedures that are not part of regular cancer care and are being
done only because you are in this study:
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 Complete five quality of life questionnaires during regularly scheduled pretreatment office visits. It will take approximately 30 minutes to complete the
questionnaires.
 You will be asked to provide samples of your tumor (if available from a previous
surgery or biopsy) and 8 teaspoons of your blood for testing that is not part of
regular cancer care and is being done only because you are in this study. You can
still participate in this study even if you do not give permission for your
tumor tissue and your blood to be submitted and used for this optional
research. For more information on this optional research, please see the last three
sections of this document. One section provides general information about the
collection and use of specimens for research. Another section describes specific
information about the use of specimens for this research study. The last section
focuses on issues regarding future research.
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.
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History and physical examination which may include a pelvic examination
Blood tests to measure blood counts, blood mineral levels and check liver and
kidney function.
You will undergo the following procedures that are not part of regular cancer care and are being
done only because you are in this study.
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Complete five quality of life questionnaires during regularly scheduled pretreatment office visits. It will take approximately 30 minutes to complete the
questionnaires.
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You will be asked to provide samples of your tumor if you require another
biopsy for clinical reasons (such as confirmation of diagnosis). If you do not
require another biopsy for clinical reasons then you DO NOT need a repeat
biopsy.
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 study
groups. Neither you nor your doctor can choose the group you will be in. You will have an
equal chance of being placed in any group.
If you are in Arm A (Control Arm) you will be given the current standard treatment for
this type of cancer and side effects and quality of life information will be collected and
compared with the intervention arm. This group will receive chemo-radiation (standard
radiation therapy plus cisplatin chemotherapy) only. This means you will receive
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standard external radiation therapy daily for five weeks. Following external radiation,
intracavitary radiation (radiation delivered directly to the cervix through the vagina) will
be administered. Depending on the type of intracavitary treatment administered, you
may receive 1-5 intracavitary placements. The administration of cisplatin will take
approximately 30-60 minutes each time. The radiation therapy will be given over eight
weeks. The cisplatin chemotherapy will be given in five treatments, weekly during the
course of the radiation therapy.
If you are in Arm B (Intervention Arm) you will be given treatment that involves more
than the standard treatment for this type of cancer. Side effects and quality of life
information will be compared with the standard arm. This group will receive chemoradiation (standard radiation therapy plus cisplatin chemotherapy), followed by
carboplatin and paclitaxel chemotherapy. This means you will receive standard external
radiation therapy daily for five weeks. Following external radiation, intracavitary
radiation (radiation delivered directly to the cervix through the vagina) will be
administered. Depending on the type of intracavitary treatment administered, you may
receive 1-5 intracavitary placements. The administration of cisplatin will take
approximately 30-60 minutes each time. The radiation therapy will be given over eight
weeks. The cisplatin chemotherapy will be given in five treatments, weekly during the
course of the radiation therapy. Within 4 weeks of finishing your radiation treatment,
you will start to receive additional chemotherapy called carboplatin and paclitaxel. These
two drugs will be given on one day, repeated every 3 weeks for 4 total cycles.
Chemotherapy with carboplatin and paclitaxel takes about 6 hours to infuse each time.
QUALITY OF LIFE
We want to know your view of how your life has been affected by cancer and its treatment.
“Quality of life” looks at how you are feeling physically and emotionally during your cancer
treatment. It also looks at how you are able to carry out your day-to-day activities.
This information will help doctors better understand how patients feel during treatments and
what effects the medicines are having. In the future, this information may help patients and
doctors as they decide which medicines to use to treat cancer.
You will be asked to complete five questionnaires at the following time points: before you are
randomized, at the end of your chemo-radiation treatment, before each cycle of treatment with
carboplatin and paclitaxel for those patients in Arm B, four weeks after completion of all study
treatment, then every 3 months for two years and then every 6 months in the 3rd year. It takes
about 30 minutes to fill out the questionnaires each time.
If any questions make you feel uncomfortable, you may skip those questions and not give an
answer.
After your treatments are completed:
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To monitor your well-being and the status of your cancer, you will undergo these tests and
procedures that are part of regular cancer care:
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History and physical examination which may include pelvic examination every three
months for two years and then every six months for three years after completion of
treatment
Blood tests to assess blood cell counts, blood mineral levels, and check liver and kidney
function if your physician feels they are necessary for monitoring
A CT scan of the chest, abdomen and pelvis six months after randomization and then as
clinically indicated by your physician
A PET scan or PET/CT scan (if available) four-six months after treatment completion
Complete five quality of life questionnaires every three months for two years and then
every six months in the 3rd year after completion of treatment.
Study Chart
If you are in Arm A, you will receive 5 weeks of external beam radiation therapy. You will
receive cisplatin intravenously (through a vein in your arm) on Day 1 of the week and radiation
on Days 1-5 followed by 2 days without treatment, for 5 weeks.
If you are in Arm B you will receive 5 weeks of external beam radiation therapy. You will
receive cisplatin intravenously (through a vein in your arm) on Day 1 of the week and radiation
therapy on Days 1-5, followed by 2 days without treatment for 5 weeks. Within 4 weeks of
completion of treatment with cisplatin and all radiation treatment, and following recovery from
any side effects, patients in Arm B will receive additional intravenous (through a vein in your
arm) treatment with the chemotherapy drugs, carboplatin and paclitaxel, every 3 weeks for four
cycles. This 3 week period of time is called a cycle.
The chart below shows what will happen to you during Cycle 1 and future treatment cycles as
explained previously. The left-hand column shows the day in the cycle and the right-hand
column tells you what to do on that day.
Arm A and Arm B (05/13/2013)
Cycle 1
Day
Within 42
days before
starting
study
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What you do
Have history taken and complete physical exam which will include a pelvic exam
Get a CT scan of the chest, abdomen and pelvis to check for any sign of cancer spread to
the rest of the body
MRI of the pelvis or PET scan of the entire body may be performed if available at your
treatment center
Complete the quality of life questionnaires
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Day 1
Days 2-5
Days 6-7
(weekend)
Day 8
Days 9-12
Days 13-14
(weekend)
Day 15
Days 16-19
Days 20-21
(weekend)
Day 22
Days 23-26
Days 27-28
(weekend)
Day 29
Days 30-33
Day 34
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Get routine blood tests and urinalysis.
A pregnancy test if you are of childbearing potential
Go to your doctor’s office and undergo planning of the radiation treatment. This may
involve examination, CT scan and X-ray. You will be there for approximately 4 hours.
Optional research blood test
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration will
take 30 to 60 minutes to infuse and then you will receive radiation therapy.
Get radiation therapy daily.
No treatment
Get routine blood tests (more if your doctor tells you to)
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration will
take 30 to 60 minutes to infuse and then you will receive radiation therapy.
As with all aspects of your cancer care, call the doctor if you do not know what to do.
Get radiation therapy
No treatment
Get routine blood tests (more if your doctor tells you to)
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 30 to 60 minutes to infuse and then you will receive radiation therapy.
As with all aspects of your cancer care, call the doctor if you do not know what to do.
Get radiation therapy daily
No treatment
Get routine blood tests (more if your doctor tells you to).
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 30 to 60 minutes to infuse and then you will receive radiation therapy.
Get radiation therapy daily
No treatment
Get routine blood tests (more if your doctor tells you to).
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 30 to 60 minutes to infuse and then you will receive radiation therapy
Get radiation therapy daily
Treatment complete for patients in Arm A
Patients in Arm B will proceed with additional chemotherapy treatments within the next
GOG-0274/RTOG 1174/ANZGOG-0902 Patient Information and Consent Form version 2.0, 21 March
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4 weeks
after your
radiation
therapy is
completed
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four weeks once any side effects have resolved
Get routine blood tests
Physical examination that may include a pelvic examination
Complete the quality of life questionnaires
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Arm B-Cycle 1 with Carboplatin and Paclitaxel
Day
Between Days
18 & 21
What you do
 Pre-chemotherapy medications by IV or mouth to prevent allergic reactions
 IV paclitaxel and carboplatin therapy. Infusion of these drugs takes approximately 6
hours
 Physical examination that may include a pelvic exam
 Routine blood tests
 Complete quality of life questionnaires
Day 22
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Days 1
Return to your doctor’s office for your next exam and to begin the next cycle.
Arm B-Cycles 2-4 with Carboplatin and Paclitaxel (05/13/2013)
Day
Days 1
Between Days
18 & 21
Day 22
4 weeks after
additional 12
weeks of
chemo is
complete
What you do
 Pre-chemotherapy medications by IV or mouth to prevent allergic reactions
 IV paclitaxel and carboplatin therapy. Infusion of these drugs takes approximately 6
hours
 Physical examination that may include a pelvic exam
 Routine blood tests
 Complete quality of life questionnaires
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Return to your doctor’s office for your next exam and to begin the next cycle.
Physical examination that may include a pelvic exam
Routine blood tests
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.
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Start Here
Patients with certain types of cervical cancer
who have given informed consent
Eligible patients
Randomize (You will be in one Group or the other)
(You will be in one Group or the other)
Arm A - Control Arm
Arm B - Intervention Arm
Standard radiotherapy plus
chemotherapy
Standard radiotherapy plus
chemotherapy, followed by
additional chemotherapy
HOW LONG WILL I BE IN THE STUDY?
You will be asked to receive cisplatin and radiation therapy for 8 weeks and if randomized to
Arm B you will receive an additional 12 weeks of chemotherapy with carboplatin and paclitaxel.
After you are finished treatment on the study, the study doctor will ask you to visit the office for
follow-up exams every three months for the first two years and then every six months for the
next three years after completion of your study treatment. If for any reason you are not able to
complete study treatment we will still ask you to visit your doctor’s office for follow up exams
and we will continue to collect data on your health status from your medical records during this
period. In the event that you withdraw from the study entirely, no further information will be
collected about you from the date we notify the study center of your withdrawal onward. We
will still maintain any data collected about your health status prior to the date you choose to
withdraw from study
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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 side effects/risks
from the study treatment 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 stop you from taking part in this study at any time if he/she thinks it is best
for you; if you do not follow the study rules; if you become pregnant; 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, doctors don’t know all the side effects that may happen.
In addition, there may be risks associated with this study that are presently unknown or
unforeseeable. The researchers don’t know whether giving the additional chemotherapy
treatment in this study might increase the chance of you getting short or longer-term side effects.
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 chemotherapy drugs
and receiving radiation. In some cases, side effects can be serious because they can be long
lasting, may never go away, may result in hospitalization, or may be life-threatening. 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 the cisplatin:
Likely
 Fatigue
 Low white blood cell counts - this may make you more susceptible to infection
 Low red blood cell counts which may cause tiredness, shortness of breath or fatigue
 Decrease in kidney function
 Loss of appetite and weight loss
 Diarrhea, constipation, nausea and vomiting, and abdominal pain
 Numbness and pain of the hands and feet
 Skin rash
 Changes in taste
 Ringing in the ears and hearing loss
 Changes in electrolytes in the blood such as magnesium and potassium
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Less Likely
 Allergic reactions
 Chills and fever with aches and pains
 Low platelet count - this may make you bruise more easily and bleed longer if injured
 Sores in mouth and throat (that can lead to difficulty swallowing and dehydration)
 Altered vision
 Skin irritation and swelling if the drug that is being put into the vein leaks into the
surrounding skin
 Complete hair loss
Rare but serious
 Seizures
 Secondary cancers such as acute leukemia
 Kidney failure requiring dialysis
 Deafness
Risks and side effects related to radiation therapy include those which are listed below. The
side effects can be serious and may require you to be hospitalized or may be irreversible, longterm, life-threatening, or fatal.
Likely:
 Tanning or reddening of the skin which is exposed to the radiation beam
 Burning or pain during urination or defecation
 Diarrhea
 Permanent pubic hair loss
Less likely but serious:
 Damage to the small or large intestine or rectum or ureter or bladder which may require
medications, hospitalization for management, or rarely a surgical procedure to repair
Rare:
 Nerve damage which may cause numbness or weakness in the legs
Risks and side effects related to the carboplatin:
Likely:
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Low white blood cell counts (this may make you more open to infection)
Low platelet count (this may make you bruise more easily and bleed longer if injured)
Low red blood cell count which may cause tiredness or shortness of breath
Tiredness
Loss of appetite and weight loss
Diarrhea, constipation, nausea and vomiting and abdominal pain
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Complete hair loss
Skin rash
Changes in taste
Changes in minerals in the blood such as magnesium and potassium
Less Likely:
 Numbness or tingling in the fingers and toes
 Ringing in the ears and hearing loss
 Allergic reactions
 Chills and fever with aches and pains
 Decrease in kidney or liver function
 Sores in mouth and throat (that can lead to difficulty swallowing and dehydration)
 Changes in vision
Rare but serious:
 Seizures
 Other cancers such as acute leukemia
 Kidney failure requiring dialysis
 Deafness
 Death
Risks and side effects related to the paclitaxel:
Likely:
 Low white blood cell count (this may make you more open to infection)
 Low platelet count (this may make you bruise more easily and bleed longer if injured)
 Low red blood cell count which may cause tiredness or shortness of breath
 Mild to severe allergic reaction which may be life-threatening with hives, wheezing, and
low blood pressure
 Numbness and pain of the hands and feet that sometimes worsens with additional
treatment and may not disappear after the drug is stopped. This may lead to difficulty
walking, buttoning clothes, etc;
 Hair loss
 Muscle weakness and muscle loss
 Muscle and joint aches
Less Likely:
 A slowing of the heart rate (a slow pulse is not harmful, however if you should develop
any other irregularities in heart rate during treatment, an EKG and other tests may be
required)
 Irregular heartbeats
 Heart attack
 Nausea and/or vomiting
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Diarrhea
Sores in the mouth or throat (that can lead to difficulty swallowing and dehydration)
Tiredness
Lightheadedness
Headaches
Kidney damage
An increase in triglyceride level (a blood lipid) levels which increases risk of hardening
of the arteries
Liver damage
Confusion or mood change
Skin tissue damage if some of the drug leaks from the vein while it is being given
Changes in taste
Irritation and swelling of the skin in an area previously treated with radiation therapy
Rash
Inflammation of the colon, pancreas or lungs
Blurred vision or other changes in eyesight such as sensation of flashing lights or spots
Rare but serious:
 Liver failure
 Swelling of the brain
 Seizures
 Death
Reproductive risks: You should not become pregnant while on this study because the drug(s)
in this study can affect an unborn baby. Women should not breastfeed a baby while on this
study. It is important you understand that if you could become pregnant, 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. If you are capable of becoming pregnant, a pregnancy test will be required before
starting the study. You should notify your health care team immediately if you think you have
become pregnant while participating in this study. Pregnancy occurring up to 6 months after
completion of the study must also be reported to the healthcare team. Your treatment may cause
temporary or permanent sterility. Please discuss this with your doctor if you have any concerns
about future fertility.
You should notify your healthcare team immediately if you think you have become pregnant
while participating in this study. Pregnancy occurring up to 6 months after completion of the
study must also be reported to the study doctor” as mentioned in section 9.2.4 of the protocol
For more information about risks and side effects, ask your study doctor.
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ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Taking part in this study may or may not make your health better. While doctors hope adding
additional chemotherapy cycles with carboplatin and paclitaxel to the usual treatment will be
more useful against cancer compared to the usual treatment alone, there is no proof of this yet.
We do know that the information from this study will help doctors learn more about carboplatin
and paclitaxel as a treatment for your type of cancer. This information could help future cancer
patients.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS STUDY?
Your other choices may include:
 Getting treatment or care for your cancer without being in a study
 Taking part in another study
 Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this study.
WHAT ABOUT CONFIDENTIALITY?
Efforts will be made to keep your personal information confidential, and GOG and RTOG
procedures may include removing your name and other identifying information from data
collected during the Study, in order to protect your privacy. However, we cannot guarantee total
confidentiality. Portions of your medical records will be sent to the Australia New Zealand
Gynecologic Oncology Group (ANZGOG), GOG Administrative Office, the GOG Statistical and
Data Center, RTOG Headquarters and possibly to the GOG Tissue Bank, and the RTOG
Biospecimen Resource, to be reviewed and analyzed by physicians and other Study personnel.
Your records may be accessed by GOG representatives, by the Cancer Trials Support Unit
(CTSU), the Food and Drug Administration (FDA), and by the NCI for research, quality
assurance, and data analysis purposes.
In addition, your records may be reviewed by the Food and Drug Administration (FDA), or other
agencies of the Department of Health and Human Services (DHHS) for research or regulatory
purposes. Also, information from the Study may be given to government agencies in other
countries where the study drug may be considered for approval.
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.
Under NCI policy, data from this Study may be provided to another researcher at some future
time for use in an approved research project. If this occurs, the researcher must agree to keep
individual patient information confidential.
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When the research results are published or discussed in conferences, no information will be
included that reveals your identity.
The National Institutes of Health (NIH) has issued GOG a Certificate of Confidentiality, which
protects GOG from being forced to disclose personal information about you in response to a
subpoena or other request in a federal or state legal proceeding.
You should understand that a Certificate of Confidentiality does not prevent you or a member of
your family from voluntarily releasing information about yourself or your involvement in this
research. If an insurer, employer, or other person obtains your written consent to receive research
information, then the researchers may not use the Certificate to withhold that information.
[Note to Local Investigators: The Department of Health and Human Services (DHHS) has
recommended that HIPAA Privacy Rule requirements be addressed by the local institution. This
may be done either in a stand-alone authorization or as part of the informed consent document,
depending on 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 all of the costs of treating
your cancer in this study, including the cost of managing the side effects of therapy. 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. You will be responsible for paying
any deductibles, coinsurance, and co-payments as required under the terms of your insurance
plan(s).
You will not be paid for taking part in this study. The institution receives payment that covers
some but not all of the costs of the 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 doctor
in person or call him/her at __________________ [telephone number].
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You will get medical treatment if you are injured as a result of taking part in this study. You
and/or your health plan will be charged for this treatment. The study will not pay for medical
treatment.
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
Taking part in this study is your choice. You may choose either to take part or not to take part in
the study. If you decide to take part in this study, you may leave the study at any time. No
matter what decision you make, there will be no penalty to you and you will not lose any of your
regular benefits. Leaving the study will not affect your medical care. You can still get your
medical care from our institution.
We will tell you about new information or changes in the study that may affect your health or
your willingness to continue in the study.
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.]
Where can I get more information?
You may call the National Cancer Institute's Cancer Information Service at:
1-800-4-CANCER (1-800-422-6237)
You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://cancer.gov/cancerinfo/
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You will get a copy of this form. If you want more information about this study, ask your study
doctor.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law.
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.
_________________________________________________________________
SIGNATURE OF PATIENT
DATE
Protocol and Consent approved by:
___________________________________________
RESEARCH COMMITTEE
DATE
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GENERAL INFORMATION ABOUT THE COLLECTION AND USE OF SPECIMENS
FOR RESEARCH (05/13/2013)
You are being asked to allow samples from your tumor (if available from a previous surgery or
biopsy) and some of your blood to be submitted and used in research. Such bodily materials are
referred to as specimens and are very important in helping doctors and scientists learn more
about caring for and treating people with cancer and other diseases. The use of specimens in
scientific research can also help doctors and scientists understand why some people develop
cancer and others don’t, why some people have or don’t have side effects to cancer therapies,
and why some people have cancers that respond or don’t respond well to current therapies, for
example.
The research that may be done with your specimens is not designed specifically to help you, but
it may help others with cancer or other diseases in the future. Reports about research done with
your specimens will not be given to you or your doctor, or be put in your health record. The
research will not have an effect on your care.
When research is performed on specimens connected with clinical information about the person,
including the person’s disease and how the person responds to treatment, doctors and scientists
can specifically study how to prevent, detect, treat and cure cancer and other diseases, or how to
predict response to therapy, toxicities, recurrence and overall survival.
The GOG and RTOG uses procedures designed to protect your privacy and confidentiality. The
chance that information from your health records will be incorrectly released is very small, but
you should be aware of this risk. To protect your privacy and confidentiality, the research
investigators that study your specimens will never be given your name, address, phone number,
Social Security number or any other personal information. In addition, your specimens will never
be labeled with your name or other type of personal identifier. Your specimens will be labeled
with a unique series of letters and numbers. The GOG and RTOG uses the unique series of
letters and numbers as confidential codes to keep track of the specimens, and sends research
investigators specimens labeled only with these codes.
Your specimens will be used for research purposes and will not be sold. However, the research
done with your specimens may help to develop new products and therapies in the future, or may
be used to establish a cell line or test that could be patented and licensed. In any event, there are
no plans to provide you with any direct financial compensation.
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If you agree now that your tumor specimens can be submitted and used for this research study
and/or for future research, your specimens will be used for research purposes until they are used
up or until you change your mind. At that time, please contact the staff at your treating
institution, typically your doctor or nurse, and tell them that you have changed your mind about
allowing your specimens to be used for research. The staff at your treating institution will notify
the GOG or RTOG regarding your wishes about using your coded specimens and clinical
information for research. If necessary, the GOG or RTOG will destroy (incinerate) all of your
specimens to make sure that they will no longer be used for research.
SPECIFIC INFORMATION FOR THIS RESEARCH STUDY (05/13/2013)
You are being asked to allow your specimens to be collected and used in research. Specimens
will only be collected from patients who give permission to allow their specimens to be used for
this research study.
The choice to let us collect your specimens and use them for this research study is up to
you. No matter what you decide to do, it will not affect your care. You can still participate in
this research study if you do not give permission to allow your specimens to be used for this
research study.
Requirements
We are asking permission to collect some of your tumor (if available from a previous surgery or
biopsy). We are also asking permission to draw some of your blood at three (or four) times
during the course of the study. About two teaspoons of blood will be draw at the following times:
1. prior to cycle 1 of treatment,
2. prior to cycle 2 of treatment, and
3. prior to cycle 3 of treatment.
Your health care team will draw an additional two teaspoons of blood at one of these times or at
a different time.
What Will Happen To Your Specimens If You Agree (05/13/2013)
If you give permission for your specimens to be submitted and used for this research study, your
health care team will send your specimens to the GOG Tissue Bank in Columbus, Ohio or to the
RTOG Biospecimen Resource in San Francisco, California for storage (banking).
The GOG Tissue Bank and RTOG Biospecimen Resource are approved by the National Cancer
Institute (NCI) to store, process, and distribute specimens from patients who agree to participate
in the studies conducted by the GOG and RTOG. The GOG Tissue Bank and RTOG
Biospecimen Resource will be responsible for sending specimens to approved laboratories for
research.
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After the research is finished, the results will be sent to the Cooperative Group that had
conducted the research (GOG Statistical and Data Center or RTOG Statistical and Data
Management Center) for analysis. The results from the laboratory testing will be studied to
determine if any of the laboratory testing may be used to identify which patients in the future
might be more or less likely to respond to the study drug, or have a good prognosis. Reports of
this research done on your specimens will not be given to you or your doctor, or be put in your
health record.
MAKING YOUR CHOICES FOR THIS RESEARCH STUDY
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
will still be allowed to participate in this research study even if you don’t want your
specimens to be submitted and used for this research study. If you have any questions,
please talk to your doctor, nurse or other type of healthcare provider.
1. Do you give permission for some of your tumor, if available from a previous surgery or
biopsy, to be submitted and used for this research study?
Yes
No
2. Do you give permission for some of your blood to be collected for submission and use for
this research study?
Yes
No
Please sign your name after you circle your answers.
 I do not wish to participate in the optional research portion of this study.
Your signature:
Signature
Doctor/Nurse:
Date:
of
Date:
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SPECIFIC INFORMATION FOR FUTURE RESEARCH (05/13/2013)
The last section of the consent will ask you to decide whether your specimens, if still available
after completion of this research study, can be stored indefinitely and used for future cancer
research or for research for health problems other than cancer. We will also ask your permission
to use the clinical information that the GOG or the RTOG will collect about you as part of your
participation in this research study to be utilized for future research that will use your specimens.
Next, we will ask for permission to contact you in the future to participate in more research.
If you agree to allow your specimens to be used for future research, there is a chance that your
specimens may be used to study changes in genetic material that are passed on in families or that
are not passed on in families but are either natural changes or influenced by environment and
lifestyle. These tests can focus on a section of genetic material (DNA), genetic material
packaged into chromosomes or examine all of the genetic material called the whole genome. The
results can then be studied to identify changes in genetic material that influence the development
of diseases including cancer or the effectiveness of specific treatments.
The choice to let us collect your specimens for future research is up to you. No matter what
you decide to do, it will not affect your care. You can still participate in this GOG and RTOG
study if you do not allow your specimens to be used for future research.
Making Your Choices About Future Research (05/13/2013)
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. If you have any
questions, please talk to your doctor, nurse or other type of healthcare provider.
1. Do you give permission for your specimens, if still available after this research study is
completed, to be used in future research to learn about, prevent, or treat cancer?
Yes
No
2. Do you give permission for your specimens, if still available after this research study is
completed, to be used in future research to learn about, prevent or treat health problems
other than cancer (for example: diabetes, Alzheimer's disease, or heart disease)?
Yes
No
3. Do you give permission for the clinical information collected by the GOG / RTOG as
part of your participation in this study to be used for future research that uses your
specimens?
Yes
No
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4. Do you give permission for your specimens, if still available after this research study is
completed, to be used for future research to study changes in genetic material?
Yes
No
5.
Do you give permission for someone from your GOG/ RTOG institution such as
your doctor or nurse to contact you in the future to ask you to take part in more research?
Yes
No
Please sign your name after you circle your answers.
 I do not wish to participate in the optional research portion of this study.
Your signature:
Date:
Signature of Doctor/Nurse:
Date:
GOG-0274/RTOG 1174/ANZGOG-0902 Patient Information and Consent Form version 2.0, 21 March
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