Download NSABP C-09 (4-9-07) - Southeast Clinical Oncology Research

IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial
Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients with Resected
or Ablated Liver Metastases from Colorectal Cancer
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.
Why have I been asked to take part in this research study?
You are being asked to take part in this study because you have a colon or rectal
cancer that has spread to your liver. One way to treat the cancer is with surgery to
remove the tumors in your liver. Another way to treat the cancer is to have surgery that
kills the tumors by either freezing the tissue or using radiowaves to kill the tumor cells.
Your doctor will decide which one or combination of these treatments is best for you.
Even though your doctor may remove the tumors or kill the tumor cells, there is a
chance that you will develop more tumors in your liver and that tumor cells will spread to
other parts of your body. The surgery may not permanently cure your cancer.
Who is conducting the study?
The National Surgical Adjuvant Breast and Bowel Project (NSABP) is conducting this
study.
(The NSABP institution must supply appropriate information as to who is
conducting the trial locally.)
Why is this research study being done?
Because the surgery may not permanently cure your cancer, you will also be given
chemotherapy. Even after your chemotherapy, there is a chance your cancer may
return. The purpose of this study is to compare the following combinations of
chemotherapy drugs to find out which is better at keeping the cancer from returning or
prolonging the time until the cancer returns.


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8 treatments of a combination of the chemotherapy drugs oxaliplatin and
capecitabine.
4 treatments of a combination of the chemotherapy drugs floxuridine (FUDR),
oxaliplatin (Eloxatin™), and capecitabine (Xeloda®) followed by 4 treatments of
oxaliplatin and capecitabine.
The combination of capecitabine and oxaliplatin is designed to circulate drug throughout
your whole body. Oxaliplatin is given through a vein in your arm and capecitabine is
taken by mouth. FUDR is delivered directly to your liver through a catheter (a small thin
tube) that is placed at the time of surgery. Chemotherapy delivered directly to your liver
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
is used to kill tumor cells that have spread to the liver, sparing some normal cells. Also,
higher concentrations of FUDR can be given when it is delivered directly to the liver.
All of these drugs have been used to treat patients with colorectal cancer that has
spread to the liver, but it is not known which combination of drugs works best for your
type of cancer.
This study is also being done to compare the side effects of the different combinations
of chemotherapy.
How many people will take part in the study?
About 400 patients will take part in the study.
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, and
procedures to find out if you can be in the study. These exams, tests, and procedures
are part of regular cancer care and may be done even if you do not join this study. If
you have had some of them recently, they may not need to be repeated:
 medical history and physical exam
 blood tests (including a pregnancy test for women who are able to bear children)
 chest x-ray
 CT or MRI scan of your abdomen and pelvis
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 be "randomized" into one of the two
treatment groups: Group 1 or Group 2. Randomization means that you are put into a
group by chance similar to the flip of a coin. 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 either of the two groups.
If you are in Group 1: You will undergo liver surgery to remove or kill the cancer.
Within 2 months after your surgery, you will begin your chemotherapy.
You will receive oxaliplatin through a vein in your arm on the first day of each
chemotherapy cycle. This will take about 2-3 hours. You will take capecitabine tablets
twice a day for 14 days, beginning on the day you receive oxaliplatin. Your doctor may
ask you to write in a diary or on a calendar each dose of capecitabine that you take.
You will then have a rest period of 1 week when you do not receive any drugs. The
treatment will restart after the 1-week rest. One treatment cycle, including the rest
period, is 3 weeks. You will receive a total of 8 cycles of chemotherapy, so your
chemotherapy will take a total of 24 weeks (about 6 months).
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If you are in Group 2: You will undergo liver surgery to remove or kill the cancer. If
you have your gallbladder, it also will be removed because the drugs you will be
receiving can cause an inflammation in your gallbladder. During the liver surgery, one
end of the catheter will be placed into an artery in your liver. The other end of the
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
catheter will be attached to an implanted pump or an implanted device called a port.
These devices are used for delivering chemotherapy to your liver. Both types of
devices are "implanted", which means that they are placed under the skin, on the right
side of the abdomen. The pumps come in more than one size, but they usually are
about 3 inches across and about 1 inch thick. They weigh about 4 to 8 ounces when
empty. The implanted port is similar to the pump but smaller. After your surgery, you
will be able to see and feel the shape of the implanted device (pump or port), but you
cannot actually see the catheter that goes from the liver to the implanted device. Your
doctor will tell you more about the type of implanted device that you will receive.
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It is possible that your surgeon will not be able to insert the catheter. It is also possible
that the catheter or pump will not work after the surgery or for some other reason you
cannot receive FUDR. These problems happen very rarely, but if they do, you will
receive the same chemotherapy as the patients in Group 1.
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Therapy following surgery
Within 2 months after your surgery, you will receive 8 cycles of chemotherapy.
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Chemotherapy Cycles 1-4
You will be given FUDR through the catheter that goes from the implanted device
(pump or port) to your liver.
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If you have the implanted pump, you will feel a pinprick when the FUDR is
injected through your skin into the pump. The pump automatically delivers the
FUDR through the catheter and into the liver. After 14 days, any remaining
FUDR is removed from the pump and a salt water solution with a drug that
prevents blood clots in the catheter will be injected into the pump.
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If you have the implanted port, an external pump is needed. This type of pump is
small and portable and can be attached to your clothing. On the first day of each
cycle of chemotherapy with FUDR, a needle is inserted through the skin into the
port. Tubing connects this needle and the pump. FUDR travels from the pump
through the tubing into the port and then is pumped through the catheter to the
liver. After 14 days, the pump is disconnected and a salt water solution with a
drug that prevents blood clots in the catheter will be injected into the port.
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Your doctor will tell you more about how the implanted device you receive will be
used to give your chemotherapy.
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After a 1 week rest period when you do not receive any drugs, you will receive
oxaliplatin through a vein in your arm. This will take 2-3 hours. Also, you will begin
taking capecitabine tablets twice a day for 14 days, beginning on the day you receive
oxaliplatin. You will then have another rest period of 1 week when you do not receive
any drugs. Thus, one full treatment cycle will take 6 weeks. The treatment will then
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
restart. You will receive 4 cycles of this chemotherapy, which will take a total of 24
weeks. If you were given an implanted pump or port, it will need to be maintained by
filling it with a salt solution for as long as the pump or port remains in place.
Chemotherapy Cycles 5-8
You will receive oxaliplatin through a vein in your arm on the first day of each cycle.
This will take about 2-3 hours. You will take capecitabine tablets twice a day for 14
days, beginning on the day you receive oxaliplatin. You will then have a rest period of
1 week when you do not receive any drugs. The treatment will restart after the 1week rest. In cycles 5-8, each treatment cycle is 3 weeks. You will receive a total of
4 cycles of this chemotherapy, which will take a total of 12 weeks.
Also, your doctor may ask you to write in a diary or on a calendar each dose of
capecitabine that you take for all cycles of chemotherapy.
If you are in Group 2, your chemotherapy will take a total of 36 weeks (about 9
months).
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
Summary of treatment:
Group 1
Group 2
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SURGERY
SURGERY
Liver surgery to remove or kill tumor cells
Liver surgery to remove or kill tumor cells and
to place the catheter (may include the
placement of a pump)
then
CHEMOTHERAPY
oxaliplatin 130 mg/m2 (given through a vein)
+
capecitabine 850 mg/m2
(taken by mouth twice a day for 14 days)
both drugs given every 3 weeks for 8 cycles
then
CHEMOTHERAPY
FUDR 0.2 mg/kg/day (given through a pump
attached to the catheter placed in your liver)
followed by
oxaliplatin 130 mg/m2 (given through a vein)
+
capecitabine 850 mg/m2
(taken by mouth twice a day for 14 days)
all 3 drugs given every 6 weeks for 4 cycles
then
oxaliplatin 130 mg/m2 (given through a vein)
+
capecitabine 850 mg/m2
(taken by mouth twice a day for 14 days)
both drugs given every 3 weeks for 4 cycles
For both Groups 1 and 2:
You will need the following tests and procedures. They are part of regular cancer care.
After your surgery, but before you begin your chemotherapy treatment, your doctor will
ask you to come in for a medical exam and history, a chest x-ray, a CT or MRI scan of
your abdomen and pelvis, and blood tests. Patients in Group 2 will also be asked to
undergo a catheter flow scan to ensure that the catheter is working properly.
Before you start each cycle of chemotherapy, you will undergo a medical exam and
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
history and blood tests. If you are in Group 2, during cycles 1-4 of chemotherapy, you
will have additional blood tests done before you begin each cycle of your oxaliplatin and
capecitabine.
When you have completed the chemotherapy, you will be asked to have a medical
exam and history.
We want to know your view of how your life has been affected by cancer and its
treatment. This "Quality of Life" study 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 2 questionnaires: one before you begin the study, and
one 4-6 weeks after your surgery. You may also be asked to complete 2 additional
questionnaires; one about 18 weeks after you begin your chemotherapy, and another
after you complete your chemotherapy. It takes about 15-20 minutes to fill out each
questionnaire.
If any questions make you feel uncomfortable, you may skip those questions and not
give an answer. You may change your mind about completing the questionnaires at
any time. If you do not answer some or all of the questions, it will not affect your taking
part in this research study.
After the treatment: For 5 years after you began the study, your doctor will ask you to
come in for follow-up exams. For the first 2 years, you will have a medical exam,
history, and blood tests every 3 months and a chest x-ray and abdominal and pelvic
scans every 6 months. During year 3, you will have all of these exams and tests every
6 months, and during years 4 and 5 you will have all of these exams once a year.
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How long will I be on the study?
Your chemotherapy will last for about 6 months if you are in Group 1 and about 9
months if you are in Group 2. You will continue to have testing every 3 months for the
first 2 years from when you entered the study, then every 6 months until 3 years from
when you entered the study, and yearly thereafter for years 4 and 5 from when you
entered the study. We would like to keep track of your medical condition for the rest of
your life.
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
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
the study 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.
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.
Can anyone else stop me from being in the study?
The study doctor may stop you from taking part in this study at any time if he or she
believes it is in the best interest for your health, if you do not follow the study rules, or if
the study is stopped by the NSABP.
What side effects or risks can I expect from being in the study?
You may have side effects while on this study. Most of these are listed here, but there
may be other side effects that we cannot predict. Side effects will vary from person to
person. Everyone taking part in the study will be carefully watched for any side effects.
However, doctors do not know all the side effects that may happen. Side effects may
be mild or very serious. Your health care team may give you medications to help lessen
some of the side effects. Many side effects go away soon after you stop taking your
study drugs. In some cases, side effects may be very serious, long-lasting, or may
never go away. There is also a risk of death.
You should talk to your study doctor about any side effects that you may have while
taking part in the study.
Risks and side effects related to oxaliplatin and capecitabine (Group 1 and Group 2)
chemotherapy include:
Likely side effects
These side effects occur in 25% or more of patients receiving oxaliplatin and
capecitabine (Group 1 and Group 2):

Diarrhea (can be very severe and life
threatening)
 Constipation

 Nausea

 Vomiting
 Tiredness
 Fatigue
 Low red blood cell count (anemia) (can
cause tiredness, weakness, and
shortness of breath)
 Low white blood cell count (may make
you more likely to get infections)
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Sores in mouth, throat, esophagus
(these may cause difficulty in
swallowing and/or heartburn)
Abdominal pain or cramps
Nerve problems that are usually
temporary, but some may be longlasting. These may be made worse
by exposure to cold temperature
and cold objects
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
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Southeast Cancer Control Consortium Consent Form

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Low platelet count that could lead to
bleeding
Nail changes
Skin problems (rash, itching, dryness,
discoloration, sensitivity to sunlight)
Blistering, drying, cracking, redness,
tingling, numbness, swelling, and/or
pain of palms of hands and bottoms of
feet (hand-foot syndrome)

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

Pain, tingling, burning, or numb feeling
(pins and needles) in hands, feet, or
area around mouth or throat, which
may cause problems walking or
performing the activities of daily living.
Trouble swallowing or saying words,
jaw tightness, odd feelings in the
tongue, chest pressure, or a feeling of
not being able to swallow or breathe
without having any physical reason for
this.
Time away from work
Cough
Temporary hair loss
These side effects occur in 10-24% of patients receiving oxaliplatin and capecitabine
(Group 1 and Group 2):

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Changes in blood test results that
indicate possible liver injury
Loss of or decrease in appetite
Taste changes
Infection





Fluid retention (bloating or swelling)
Eye problems (including tearing,
irritation, and visual disturbances)
Fever
Headache
Shortness of breath
Less likely side effects
These side effects are less likely, occurring in 3-9% of patients receiving oxaliplatin
and capecitabine (Group 1 and Group 2):











Dehydration
Weight loss
Heartburn
Nasal stuffiness
Dizziness
Chest pain
Upset stomach
Poor coordination and balance
Mood changes (including depression)
Allergic reaction (including itching,
hives, flushing, skin rashes, fever,
chills, muscle stiffening)
Rapid heart beat
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
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
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Pain (in the chest, back, joints,
muscles, limbs)
Gastrointestinal ulcers or bleeding
Irritation of the vein used to administer
the drug
Fever with a low white blood cell count
Changes in blood test results that
indicate possible kidney damage
Blood clots
Difficulty sleeping
Hiccups
Hot flashes/flushing
Inflammation of the veins
Involuntary movements
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
Rare but serious side effects
These side effects are rare but serious, occurring in less than 3% of patients receiving
oxaliplatin and capecitabine (Group 1 and Group 2):






Heart problems
Changes in blood pressure
Diarrhea with low white blood cell count
that can be severe
Changes in the lungs (including
inflammation, thickening, scarring, and
possible lung failure)
Skin and tissue damage in the area
surrounding the catheter where the
chemotherapy is injected
Irregular heartbeat





Problems with hearing
Visual changes (including complete
vision loss usually lasting less than a
minute)
A breakdown of red blood cells and
kidney failure known as hemolytic
uremic syndrome
Severe allergic reaction (including
shortness of breath, wheezing, chest
tightness, low blood pressure, severe
breathing problems)
Liver damage that may be permanent,
including a serious form called "venoocclusive disease" which can cause
swelling of the abdomen, painful
swelling of the liver, and yellowing of
the skin
Diarrhea that occurs at the same time as low white blood cell counts can lead to a very
serious, life-threatening infection. On rare occasions, this can be fatal. Diarrhea can
also be a sign of other serious intestinal problems. It is very important that you tell the
study staff if you are having diarrhea so they can watch over your condition. You may
need to be hospitalized to receive supportive care.
Risks and side effects related to hepatic arterial infusion of FUDR (Group 2)
include:
Likely side effects
These side effects are likely, occurring in 10-24% of patients receiving hepatic arterial
infusion (Group 2):

Low red blood cell count (anemia) (can
cause tiredness, weakness, and
shortness of breath)
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Low white blood cell count (may make
you more likely to get infections)
Low platelet count that could lead to
bleeding
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
Less likely side effects
These side effects are less likely, occurring in 3-9% of patients receiving hepatic
arterial infusion of FUDR (Group 2):




Infection
Diarrhea
Nausea
Vomiting


Sores in mouth, throat, esophagus
(these may cause difficulty in
swallowing and/or heartburn)
Ulcers or inflammation of the stomach
or intestines
Rare but serious side effects
These side effects are rare but serious, occurring in less than 3% of patients receiving
hepatic arterial infusion of FUDR (Group 2):




Irreversible injury to the liver
Gastrointestinal ulcers or bleeding
Infection at catheter site or in pump
pocket
Bleeding at catheter site


Blockage, leakage, or movement of
catheter
Damage to the bile ducts that could
result in irreversible scarring of the liver
During the study, we will do blood tests to see if the dose of some of the drugs you are
receiving should be changed or delayed. The tests will also help monitor any side
effects you may have. You will not need to be hospitalized unless you have serious
side effects.
You are at risk for any of these side effects for as long as you are receiving treatment as
part of this study. There may be other side effects that we cannot predict. You should
discuss risks and side effects with the study doctor at phone # ___________________,
or with your regular doctor.
Risks related to surgery: Your surgeon will explain the risks that are related to your
surgery. You may also be asked to sign a consent form for your surgery.
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Risks related to fertility and pregnancy: The drugs in this study can affect an unborn
baby. Therefore, women should not become pregnant and men should not father a
baby while on this study. The drugs in this study may also affect your ability to have
children. Both men and women 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), Norplant,
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
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Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
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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 within 14 days prior to study entry is
required.
Secondary Malignancies: A number of established chemotherapeutic drugs have an
inherent (basic) risk of causing secondary cancers and/or leukemias (cancer of the
white blood cells). Certain drugs in use today, not currently known to be associated
with this risk, may be shown at a later time to result in the development of these
secondary cancers and/or leukemias, which may not be reversible.
For more information about risks and side effects, ask your study doctor.
Are there benefits to taking part in this study?
Taking part in this study may or may not make your health better. All of the drugs used
in this study have been given to patients with colorectal cancer that has spread to the
liver, but it is not known which combination of drugs works best. 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
 If you choose not to get treatment and your cancer spreads further, you can get
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.
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
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
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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
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Sanofi-Synthelabo Inc., the makers of oxaliplatin
Roche Laboratories, Inc., which is supplying the capecitabine free of charge
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
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?
You and/or your health plan/insurance company (Medicare should be considered a
health insurance provider) will need to pay for all of the costs of treating your cancer in
this study except for those described below in this section. 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 surgery,
clinical visits, any hospital admissions, laboratory tests, x-rays, scans, chemotherapy
treatments, radiation treatments, procedures, and any other tests. Please ask your
doctor about any added costs or insurance problems.
Roche Laboratories, Inc. will provide you with the capecitabine free-of-charge for this
study.
Every effort will be made to ensure adequate supplies of the capecitabine, free-of10/5/05
Page 12 of 16
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
charge, for all patients. Oxaliplatin and FUDR are commercially available and you or
your insurance company will be responsible for their cost. There may be costs which
are not covered by the study such as co-pays and doctor's fees. There may be
additional costs to you or your insurance provider for the pump and the doctor's fee
associated with the placement of the pump.
You will not be paid for taking part in this study.
For more information on clinical trials and insurance coverage, you can visit the National
Cancer Institute's Web site at http://cancer.gov/clinicaltrials/understanding/insurancecoverage. 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, _________________________ 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
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 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.
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
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Page 13 of 16
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
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.
The Data Monitoring Committee (DMC), an independent group of experts, will be
reviewing the data from this research throughout the study. 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. You may be asked to sign another consent form in response to
new information.
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?
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 ___________________).
You may also call the Operations Office of the NCI Central Institutional Review Board
[CIRB] at 888-657-3711 [from the continental U.S. only].
Additional tests for NSABP C-09 study
The following section of the informed consent form is about additional research studies
that may be 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 part of the main study even if
you say "no" to taking part in these additional studies.
Consent for use of blood and tissue for future research
About using blood and tissue for future research: The NSABP would like to keep some
of the tissue that is taken during your liver surgery and some of the blood that is taken
during the study but is not used for other tests. If you agree, the blood and tissue
samples will be kept and may be used in future research to learn more about cancer
and other diseases. The blood and tissue will be given only to researchers approved by
the NSABP. Any research study using your samples must also be approved by an IRB.
The research that may be done with your blood and tissue is not designed to specifically
help you. It might help people who have cancer and other diseases in the future.
Reports about research done with your samples will not be given to you or your doctor.
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Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
These reports will not be put in your health records. The research using your blood
and tissue samples will not affect your care.
Things to think about: The choice to let the NSABP keep the blood and tissue samples
for future research is up to you. No matter what you decide to do, it will not affect your
care in this study. If you decide now that your blood and tissue samples 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 the NSABP to use your blood and tissue samples
and they will no longer be used for research. Otherwise, they may be kept until they are
used up, or until the NSABP decides to destroy them.
In the future, people who do research with your blood and tissue samples may need to
know more about your health. While the NSABP may give them reports about your
health, they will not give them your name, address, phone number, or any other
information that will let the researchers know who you are.
Sometimes blood and tissue samples are used for genetic research (about diseases
that are passed on in families). Even if your blood and tissue samples are used for this
kind of research, the results will not be told to you and will not be put in your health
records.
Your blood and tissue samples will be used only for research and will not be sold. The
research done with your samples may help to develop new products in the future, but
you will not get paid.
Benefits and risks: The possible benefits of research from your blood and tissue include
learning more about what causes cancer and other diseases, how to prevent them and
how to treat them. The greatest risk to you is the release of information from your
health records. The NSABP will protect your records so that your name, address, and
phone number will be kept private. The chance that this information will be given to
someone else is very small. There will be no cost to you for any blood or tissue
collected and stored by the NSABP.
Making your choice: Please read each sentence below and think about your choice.
After reading each sentence, circle "yes" or "no." If you have questions, please talk to
your doctor or nurse. Remember, no matter what you decide to do about the storage
and use of your blood and tissue samples, you may still take part in the C-09 study.
Indicate your choices by circling "Yes" or "No" after each statement.
1. My blood and tissue may be kept by the NSABP for use in future research to learn
about, prevent, detect, or treat cancer.
YES
10/5/05
NO
Page 15 of 16
Participant Initials ____
IRB Approval Date ____________
Version Date: 4/9/07; Amendments 1+2
Broadcast Date: 8/9/07
APPENDIX J
NSABP C-09
Southeast Cancer Control Consortium Consent Form
2. My blood and tissue samples may be used for research about other health problems
(for example: causes of heart disease, osteoporosis, diabetes).
YES
NO
3. My study doctor (or someone he or she chooses) may contact me in the future to
ask me to take part in more research.
YES
4/9/07
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



4/9/07
NO
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 16 pages of this consent. 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)
10/5/05
_________________________________
(Signature of Person Obtaining Consent)
Page 16 of 16
NSABP C-09
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 ___________
10/5/05
NSABP C-09
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 __________
10/5/05