IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
A Phase II Study to Determine the Efficacy and Safety of
Panitumumab in Combination with Chemoradiotherapy for Unresectable
or Locally Recurrent Adenocarcinoma of the Rectum
With or Without Metastatic Disease
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 study?
You are being asked to take part in this study because you have cancer of the rectum
that will not be removed by surgery at this time. Your doctor has told you that other
treatments, including a combination of drugs and radiation therapy, are recommended
at this time.
Who is conducting the study?
The National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation
Research Program (FRP) is conducting the study.
(The NSABP institution must supply appropriate information as to who is
conducting the trial locally.)
Why is this study being done?
There are several reasons why this study is being done:

To learn how rectal cancer tumors such as yours respond to a combination of
chemotherapy drugs plus another new drug called panitumumab given before
radiation therapy begins and then along with radiation therapy of the pelvis.
 The chemotherapy drugs used in this study are oxaliplatin and capecitabine.
Both are commonly used to treat rectal cancer.
 Panitumumab is an investigational drug (still being researched) and is a type of
drug called a monoclonal antibody. Panitumumab attaches to an area found on
normal cells and on cancer cells called an epidermal growth factor receptor.
When panitumumab attaches to this area on the cell, it blocks a protein called
epidermal growth factor (EGF) from being able to attach to the cell. When EGF is
blocked, the growth of the cell slows down or stops. Panitumumab may also help
radiation therapy work better.
6/27/06
Page 1 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
 To determine if adding panitumumab to chemotherapy and radiation therapy will help
decrease the size of your rectal cancer.
 To learn if your tumor will respond well enough to the panitumumab, chemotherapy,
and radiation therapy treatments to make it possible for your surgeon to remove your
tumor by surgery.
 To learn about the side effects of panitumumab when combined with chemotherapy
and with the combination of chemotherapy and radiation therapy.
How many people will take part in the study?
About 65 people will take part in this 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 or
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 the study. If
you recently have had any of these tests, exams, or procedures listed below, they may
not need to be repeated. This will be up to your study doctor.
 medical history and physical exam
 an examination by a surgeon to be sure you are not a candidate for surgery at this
time
 blood tests to check your blood counts and how well your kidneys and liver are
working
 CT scan of your chest
 CT or MRI scan of your abdomen and pelvis
 PET scan of your whole body
 endoscopic exam (a procedure using a scope to examine your rectum and colon)
 pregnancy test (if you are a woman of childbearing potential)
You will also need the following blood test which is not part of regular cancer care and
are being done for the purpose of this study:
 blood test to measure the amounts of calcium, potassium, and magnesium in your
blood.
During the study: If the exams, tests, and procedures listed above show that you can be
in the study, and you choose to take part, you will begin study treatment within 2 weeks
after joining the study. Your study treatment will be divided into two parts.
7/28/06
Part 1: During the first part, you will be treated with the drugs oxaliplatin, capecitabine,
and panitumumab. You will receive these study drugs beginning every 14 days. The
14 days between the first day you receive your therapy and the next time you receive
your therapy is called a cycle. On the first day of each cycle, you will receive
panitumumab through a vein. This will take about 30-60 minutes. After receiving
panitumumab, oxaliplatin will be given through a vein. This will take about 2 hours.
6/27/06
Page 2 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Also, on the same day, you will begin taking another chemotherapy drug called
capecitabine. Capecitabine is taken by mouth with a full glass of water twice a day
about 30 minutes after eating breakfast and dinner. You will take capecitabine for the
first 7 days of each 14-day cycle. Your doctor may ask you to keep track of the
capecitabine pills you take by writing in a diary or on a calendar. After taking
capecitabine for 7 days, you will have 7 days without treatment. The oxaliplatin,
capecitabine, and panitumumab will be repeated every 14 days for 4 cycles. Part 1 of
your therapy will take about 8 weeks.
After you complete the first part of your study treatment, you will have a rest period of
about 1 to 2 weeks.
Part 2: During the second part of your treatment, you will receive panitumumab and
capecitabine in addition to radiation therapy to your pelvis which includes the rectal
tumor area.
You will receive radiation therapy 5 days out of every 7 days (usually Monday through
Friday) for about 6 weeks. On the first day of each week, you will receive panitumumab
through a vein over a period of about 30-60 minutes. You will receive panitumumab
once a week for 6 weeks. Also on the first day of each week, you will again begin
taking capecitabine by mouth twice a day with a full glass of water about 30 minutes
after eating breakfast and dinner. During this part of your treatment, you will take
capecitabine 5 days a week on the days you are scheduled to receive radiation therapy
(for about 6 weeks). If, for some reason, you miss your regularly scheduled radiation
therapy treatment, you will still take the capecitabine doses for that day. Your doctor
may ask you to write in a diary or on a calendar to record each dose of capecitabine
that you take.
Because these drugs are being given at the same time as radiation therapy, the doses
of both capecitabine and panitumumab are lower than the doses used during Part 1 of
therapy.
6/27/06
Page 3 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
A summary of your study treatment is outlined below:
TREATMENT – PART 1
Panitumumab + Oxaliplatin
given through a vein on Day 1 every 14 days for 4 cycles
+
Capecitabine
taken by mouth twice a day on Days 1 through 7 every 14 days for 4
cycles
TREATMENT – PART 2
Radiation Therapy
5 days a week for about 6 weeks
+
Panitumumab
given through a vein once a week for 6 weeks
+
Capecitabine
taken by mouth twice a day for 5 days a week on the days
you are scheduled to receive radiation therapy (about 6 weeks)
Surgery may or may not follow the completion of study therapy.
During Part 1 of your study therapy:
You will have the following tests and exams. They are part of regular cancer care.
 physical exam before every cycle of therapy
 blood tests to check your blood counts before every cycle
 blood test to check how well your kidneys and liver are working every other cycle
You will also have the following test every 4 weeks which is not part of regular cancer
care and is being done for the purpose of this study:
 blood test to check the levels of magnesium, potassium, and calcium in your blood
After you complete the first part of your therapy:
You will have the following tests and exams. These tests and exams will be done
before you begin radiation therapy. They are part of regular cancer care.
 physical exam
 blood tests to check your blood counts and how well your kidneys and liver are
working
 CT scan to help plan your radiation therapy treatments
6/27/06
Page 4 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
You will also have the following test which is not part of regular cancer care and is being
done for the purpose of this study:

Blood test to check the levels of magnesium, potassium, and calcium in your
blood
During Part 2 of your study therapy:
While you are receiving capecitabine, panitumumab, and radiation therapy, you will
have the following tests and exams at least every 2 weeks. They are part of regular
cancer care.
 a physical exam
 blood tests to check your blood counts
 blood tests to check how well your kidneys and liver are working
You will also have the following test every 2 weeks which is not part of regular cancer
care and are being done for the purpose of this study:
 blood test to check the levels of magnesium, potassium, and calcium in your blood
After your study therapy:
About 4-6 weeks after completion of your study therapy, you will have the following tests
and procedures. All of these are part of regular cancer care with the exception of the
blood tests to check the levels of magnesium, potassium, and calcium in your blood and
the PET scan.





physical exam
blood tests to check your blood counts and how well your kidneys and liver are
working
blood tests to check the levels of magnesium, potassium, and calcium in your blood
CT scan of your chest (if you had any areas of tumor in your chest before you joined
the study.)
CT scan or MRI of your abdomen and pelvis
 If the CT scan or MRI of your abdomen and pelvis shows your rectal tumor has
not decreased in size, your doctor will discuss further treatment options with
you.
 If the CT scan or MRI of your abdomen and pelvis shows your pelvic tumor has
decreased in size or shows no signs of remaining tumor in your pelvis, and
your study doctor and surgeon recommend surgery to remove tissue from the
area where your tumor had been, then your study doctor will schedule a PET
scan before surgery. You will also have an examination of your rectum using a
scope to look closely at the area where your rectal tumor had been to confirm
your tumor's response to the study therapy (this may be done at the time of
your surgery).
6/27/06
Page 5 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
 If the CT scan or MRI of your abdomen and pelvis shows your pelvic tumor has
decreased in size or shows no signs of remaining tumor, and your doctor has
determined it is not in your best interest to have surgery to remove your rectal
tumor, you will then be scheduled to have a PET scan, as well as a repeat CT
or MRI scan of your abdomen and pelvis, about 6 weeks later to again check
your tumor’s response to the study therapy. If the PET scan and repeat CT
scan or MRI show that your tumor has responded well enough to the study
treatment, your doctor will schedule an examination of your rectum using a
scope to check the area where your tumor was located to confirm whether or
not there is visible rectal tumor remaining.
If surgery is performed:
You will have a doctor’s visit to see how you are doing about 8 weeks after your
surgery.
Whether or not you have surgery:
We would like to continue to check on your health status about 12, 18, and 24 months
from the time you joined the study.
How long will I be in the study?
You will be in the study for 2 years. During that time, your study therapy will last for
about 4 months, unless your cancer gets worse or you or your doctor decide you should
stop. You will have tests and exams to check how your cancer responded to the
therapy during the 1-3 months after you complete your radiation therapy. The NSABP
would like to keep track of your medical condition about every 6 months for 2 years from
the time you joined the study.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping so any risks from
the study therapy 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 will be
most helpful for you.
You can choose to withdraw in one of two ways. In the first way, you can stop your
study treatment, but still allow the study doctor to report your health status to the
NSABP Foundation Research Program until 2 years after you jointed the study. In the
second, you can stop your study treatment and request that no new information be
reported to the NSABP.
6/27/06
Page 6 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Can anyone else stop me from being in the study?
Your 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 the study. Everyone taking part in the study will be
watched carefully 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 healthcare team may
give you medicines to help lessen side effects. Many side effects go away soon after
you stop taking the study therapy. In some cases, side effects can be serious, longlasting, 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 have while taking
part in the study.
Risks and side effects related to oxaliplatin include those which are:
Likely
These side effects occur in 25% or more of patients receiving oxaliplatin:
 Nerve problems that are usually
temporary, but some may be longlasting. These may be made worse by
exposure to cold temperature and cold
objects

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.
 Abdominal pain or cramps
 Temporary loss of hair










Nausea
Vomiting
Diarrhea
Fatigue
Sores in mouth, throat, and esophagus,
(the tube that goes from the mouth to
the stomach)
Low platelet count (which may lead to
increased bruising or bleeding)
Lowered red blood cell count (may lead
to tiredness, weakness and shortness
of breath)
Low white blood cell count (may lead to
infection)
Cough
Time away from work
Side effects that occur in 10-24% of patients receiving oxaliplatin.


Changes in blood tests that may
indicate liver injury
Fever
6/27/06
Page 7 of 16


Loss of appetite
Infection
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Less Likely
These side effects occur in 3-9% of patients receiving oxaliplatin:
 Headache
 Blistering, peeling, redness, swelling,
tingling, numbness, and/or pain of the
palms of hands and bottoms of feet
 Rash
 Inflammation of the veins
 Allergic reaction (including itching,
hives, skin rash, fever, chills, muscle
stiffening, sinus congestion, or swelling)
 Intestinal blockage
 Bowel wall changes (that may require
hospitalization)
 Irritation of the intestines
 GI ulcers and bleeding
 Problems with hearing
 Visual changes (including blindness
that lasts less than a minute)
 Rapid heartbeat
 Irregular movements


















Constipation
Taste changes
Shortness of breath
Pain in muscles, bones, or joints
Changes (high or low) in blood
pressure
Hot flashes/flushing
Dehydration
Fever with a low white blood cell count
Chest pain
Dizziness
Mood changes (including depression)
Blood clots
Changes in blood test that may indicate
kidney damage
Hiccups
Weight loss
Eye problems (including redness and
irritation)
Poor coordination and balance
Difficulty sleeping
Rare, but Serious
These side effects occur in less than 3% of patients receiving oxaliplatin:
 Changes in the lungs (including
inflammation, thickening, scarring, and
possible lung failure)
 A breakdown of red blood cells and
kidney failure known as hemolytic
uremic syndrome
 Severe allergic reaction including
shortness of breath, low blood
pressure, wheezing, chest tightness,
and severe breathing problems
6/27/06
Page 8 of 16




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
Skin and tissue damage in the area
surrounding the catheter where the
chemotherapy is injected
Irregular heartbeat
Clots that form in the blood and use up
the substances needed to stop
bleeding
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Risks and side effects related to capecitabine include those which are:
Likely
These side effects occur in 25% or more of patients taking capecitabine:






Diarrhea (can be very severe and lifethreatening)
Nausea
Vomiting
Loss of appetite
Sores in mouth, throat, and
esophagus (these may cause difficulty
in swallowing and/or heartburn)
Redness, swelling, pain, numbness,
tingling, cracking, blistering, and
peeling of the hands and feet (handfoot syndrome)








Eye problems
Tiredness
Abdominal pain
Skin problems (rash, itching, and
dryness)
Changes in liver function tests
Time away from work
Change in ability to perform activities
of daily living
Low white blood cell count (may lead
to infection)
These side effects occur in 10-24% of patients taking capecitabine:
 Fever
 Headache
 Swelling
 Mouth discomfort
 Pain including back pain



Tingling in the arms and feet
(peripheral neuropathy)
Constipation
Eye irritation
Less Likely
These side effects occur in 3-9% of patients taking capecitabine:









Dehydration
Weakness
Dizziness
Nail changes
Cough
Shortness of breath
Depression
Hair loss
6/27/06






Page 9 of 16
Decreases in hemoglobin (the part of
the blood cells that carry oxygen)
Fever with a low white blood cell
count
Skin discoloration
Gastrointestinal bleeding
Mood changes
Taste changes
Difficulty sleeping
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Rare, but Serious
These side effects occur in less than 3% of patients taking capecitabine:

Heart problems

Chest pain

Low platelet count that may lead to increased bruising or bleeding

Infection

Changes in blood pressure

Blood clots
Risk and side effects related to panitumumab include those which are:
7/28/06
Likely
These side effects occur in 25% or more of patients receiving panitumumab:

Skin Rash. One of the most common side effects to occur with panitumumab is a
mild to moderate skin rash. Over 90% of all patients experience some skin rash
during therapy with panitumumab. This rash commonly resembles acne. The rash
often appears on the face and upper chest but can affect any area of the skin.
Some patients have experienced itching or pain with the rash. You should avoid
being in the sun for extended periods of time because sunlight can make the rash
worse. It is recommended that you wear sunscreen as well as protective clothing
and a hat when outdoors. If you develop a rash, your study doctor may decide to
treat the rash with medications or may hold the panitumumab until the rash gets
better. The rash usually goes away once the panitumumab is discontinued.



Diarrhea
Dry skin
Itching
Decreased amount of magnesium in the blood
7/28/06
●
7/28/06
These side effects occur in 10-24% of patients receiving panitumumab:



7/28/06
7/28/06
●
●
Sores in the mouth, throat, and the esophagus which is the tube that goes from the
mouth to the stomach
Infection of the nail bed (fingers or toes)
Fissures (small cracks or splitting) of the skin on the fingertips or toes
Cough
Shortness of breath
6/27/06
Page 10 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
7/28/06
Less Likely
These side effects that occur in 3-9% of patients receiving panitumumab:
7/28/06
●

7/28/06
Eye problems (including increased tearing, redness, itchiness, dry eyes, and
blurred vision)
Swelling in hands or feet
Rare, but Serious
These side effects occur in less than 3% of patients receiving panitumumab:
7/28/06
7/28/06
7/28/06
 Decreased amount of calcium in the blood
 Lung complications (known as pneumonitis or fibrosis)
● Abnormal collection of fluid in the space between the lung and the wall of the chest
cavity (pleural effusion)
● Blood clots in the legs
 Blood clot that could travel to the lungs
 Stroke
 Heart attack
 Severe skin infection
● Allergic reaction (including itching, hives, fever, chills, flushing, wheezing, shortness
of breath, irregular heartbeat, drop in blood pressure, sweating, and swelling around
your mouth and eyes)
 Reaction during the infusion (such as fever, chills that can be severe, low blood
pressure, wheezing, nausea, and rash and itching)
Risks related to radiation therapy: Your radiation therapy doctor will explain the side
effects that may result from your radiation therapy. The drugs given in this study may
make these side effects more severe.
10/30/06
Risks related to fertility and pregnancy: The drugs in this study as well as the
radiation therapy, can be harmful to an unborn baby. Therefore, women should not
become pregnant and men should not father a baby while on this study. 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
immediately. A pregnancy test may be performed.
6/27/06
Page 11 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
Male patients should also inform the study doctor immediately if their sexual partners
become pregnant while the patient is receiving treatment. 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.
Men and women should continue to take contraceptive precautions for at least 6 months
after their last dose of panitumumab. Women should not breastfeed a baby while on
this study and for at least 6 months after the last dose of panitumumab.
Since most methods of birth control are not 100% reliable, if you are a sexually active
woman of childbearing potential, a blood pregnancy test within 7 days of 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 the study?
Taking part in this study may or may not make your health better. While doctors hope
these drugs will be effective in treating rectal cancer, there is no proof of this yet. We
do know that the information from this study will help doctors learn more about these
drugs as a treatment for cancer. This information could help future cancer patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:



Getting treatment or care for your cancer without being in a study
Taking part in another study
Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this
study.
10/30/06
Will my medical information be kept private?
We will do our best to make sure that the personal information in your medical record
will be kept private. However, we cannot guarantee total privacy. Your personal
information may be given out if required by law. If information from this study is
published or presented at scientific meetings, your name and other personal information
will not be used.
6/27/06
Page 12 of 16
Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
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
 The National Surgical Adjuvant Breast and Bowel Project (NSABP)
Foundation Research Program (FRP)
 Amgen, Inc., which is the company supplying the study drug panitumumab for
the study
 International Drug Development Institute (IDDI), which is the company that
will analyze the data for this study
 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 provider (Medicare should be considered a
health insurance provider) will need to pay for some or all of the costs of treating your
cancer in this study. Some health plans will not pay these costs for people taking part in
studies. Check with your health plan or insurance company to find out what they will
pay for. Taking part in this study may or may not cost your insurance company more
than the cost of getting regular cancer treatment. You or your insurance carrier will be
responsible for the costs of clinic visits, any hospital admissions, laboratory tests, xrays, scans, chemotherapy treatments, radiation treatments, and any other tests.
Please ask your doctor about any added costs or insurance problems.
Tests, procedures, or drugs for which there is no charge in this study:
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Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
 Blood tests to measure the amount of calcium, potassium, and magnesium in the
blood. These blood tests will be done before you join the study and at the scheduled
time points described earlier in this consent form.
 PET scan performed after your study therapy is done.
 Panitumumab will be provided for this study at no cost to you by Amgen, Inc.
However, you or your insurance company will need to pay for costs of the supplies
and personnel who give you the drug. If, during the study, panitumumab is approved
for use in rectal cancer, you and/or your health plan may have to pay for drug
needed to complete this study.
Oxaliplatin and capecitabine are available commercially, and you or your insurance
company will be responsible for their costs. You or your insurance company will also
need to pay for costs of the supplies and personnel who give you the drugs.
The radiation therapy you receive in this study is considered the standard treatment for
patients with your stage of rectal cancer. Therefore, you and/or your insurance
company will be responsible for the costs of the radiation therapy.
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.
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Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
What are my rights if I take part in this study?
Taking part in this study is voluntary. You may choose to take part, not to take part, or
may leave the study at any time. No matter what decision you make, there will be no
penalty to you and you will not lose any of your regular benefits. Leaving the study will
not affect your medical care or result in any penalty or loss of benefits to which you are
entitled.
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study. You may be asked to sign another consent form in response to
new information.
10/30/06
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
__________________________).
Participant Contract
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.
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Participant Initials _____
IRB Approval Date: ______________
Version Date: 7/28/06; Amendment #1
Updated 10/30/06
Appendix I
NSABP FR-1
Southeast Cancer Control Consortium Consent Form
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)
6/27/06
_________________________________
(Signature of Person Obtaining Consent)
Page 16 of 16
NSABP FR-1
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 ___________
6/27/06
NSABP FR-1
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 __________
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