Download RTOG 0212 - Southeast Clinical Oncology Research Consortium

IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
APPENDIX I
RTOG 0212
Southeast Cancer Control Consortium Consent Form
A PHASE II/III RANDOMIZED TRIAL OF TWO DOSES (PHASE III-STANDARD vs.
HIGH) AND TWO HIGH DOSE SCHEDULES (PHASE II – ONCE vs. TWICE DAILY)
FOR DELIVERING PROPHYLACTIC CRANIAL IRRADIATION FOR PATIENTS WITH
LIMITED DISEASE SMALL CELL LUNG CANCER
What Is a Research Study?
This is a clinical trial (a type of research study). Clinical trials include only
patients who choose to take part. Please take your time to make your decision.
Discuss it with your friends and family. The National Cancer Institute (NCI)
booklet, “Taking Part in Clinical Trials: What Cancer Patients Need To Know,” is
available from your doctor.
You are being asked to take part in this study because you have small cell lung
cancer, which may spread to the brain.
Why Is This Study Being Done?
12/6/05
(For patients enrolled on or before 12/31/05)
In fifty percent of patients with small cell lung cancer, the cancer will spread to
the central nervous system at some time during the course of their disease. The
purpose of this study is to compare the effectiveness of standard dose and high
dose brain irradiation in preventing small cell lung cancer from spreading to the
brain. In addition, the study will compare the effectiveness of two schedules of
high dose brain irradiation in preventing lung cancer from spreading to the brain.
The study also will find out the effects (good and bad) of brain irradiation on you,
including how your thinking skills and the quality of your life are affected.
12/6/05
(For patients enrolled after 12/31/05)
In fifty percent of patients with small cell lung cancer, the cancer will spread to
the central nervous system at some time during the course of their disease. The
purpose of this study is to compare the effects (good and bad) of three different
regimens of brain irradiation on patients’ thinking skills and quality of life.
How Many People Will Take Part In The Study?
About 264 people will take part in this study.
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Page 1 of 7
Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
APPENDIX I
RTOG 0212
Southeast Cancer Control Consortium Consent Form
What Is Involved In The Study?
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You will be “randomized” into one of the study groups described below.
Randomization means that you are put into a group by chance. It is like flipping a
coin. A computer will determine the treatment into which you are placed. You will
have an approximately one in 2 chance of receiving Treatment 1 below (standard
dose) and a one in four chance of receiving either Treatment 2 or 3 below (high
dose).
Treatment 1:
If you are randomized to this treatment, you will receive standard dose brain
irradiation once a day, Monday through Friday, for approximately 10 treatment
days.
Treatment 2:
If you are randomized to this treatment, you will receive high dose brain
irradiation once a day, Monday through Friday, for approximately 18 treatment
days.
Treatment 3:
If you are randomized to this treatment, you will receive high dose brain
irradiation twice a day, Monday through Friday, for approximately 12 treatment
days. Each treatment day, you will need to return for your second treatment six to
eight hours after your first treatment.
In addition you will have the following tests and procedures:
 A physical exam prior to treatment, every 6 months for the first year after
treatment and then annually for 3 years
 Blood tests prior to study entry
 A chest x-ray and/or a chest CT scan prior to treatment and every 6
months for the first year after treatment
 A brain CT or MRI scan prior to study entry, every 6 months for the first year
after treatment and then annually for 3 years
 Written and verbal tests to evaluate your memory and thinking skills, and 2
questionnaires about your quality of life prior to study entry, every 6 months
for the first year after treatment, and then annually for 3 years. These tests
will take a total of about 40 minutes each time you complete them.
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Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
RTOG 0212
Southeast Cancer Control Consortium Consent Form
How Long Will I Be In The Study?
Depending on which schedule of treatment you receive, you will receive brain
irradiation for either 2-3 or 3-4 weeks. Follow-up visits, including completion of
tests to evaluate your memory and thinking abilities and 2 questionnaires about
your quality of life, will continue for 3 years.
The researcher may decide to take you off this study if side effects become very
severe, if you become too ill to continue, or if your doctor feels this treatment is
no longer in your best interest.
You can stop participating at any time. However, if you decide to stop
participating in the study, we encourage you to talk to the researcher and your
regular doctor first.
What Are The Risks Of The Study?
While on the study, you are at risk for these side effects. You should discuss
these with the researcher and/or your regular doctor. There also may be other
side effects that we cannot predict. Other drugs will be given to make side effects
less serious and uncomfortable. Many side effects go away shortly after the brain
irradiation is stopped, but in some cases side effects can be serious or longlasting or permanent.
Brain Irradiation
Very Likely
 Hair loss, which may be permanent
 Scalp reddening or tanning and irritation
 Dry mouth and/or change in taste
 Nausea and/or vomiting
 Headaches
 Tiredness
Less Likely, But Serious
 Drainage from the ears or plugging of the ears with decreased hearing
 Memory loss, behavioral change, and/or increased sleepiness (occurring
4-10 weeks after radiation therapy is complete and lasting for several days
up to 2 weeks)
 Cataracts and eye damage with the possibility of blindness
 Severe local damage to normal brain tissue, which may require surgery
 In very rare cases, death may result from brain irradiation.
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Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
RTOG 0212
Southeast Cancer Control Consortium Consent Form
Blood Draws
Very Likely
 Bleeding and/or bruising at the site
 Discomfort/anxiety about needles
Less Likely, But Serious
 Risk of infection at the site
Reproductive Risks (Pregnancy/Birth Control): Due to the unknown risks
and potential harm to the unborn fetus, sexually active women of childbearing
potential and men who could father a baby must use a reliable method of birth
control while participating in this study. Reliable methods of birth control are
considered to be: abstinence (not having sex), oral contraceptives, Intrauterine
Device (IUD), DepoProvera, Norplant, tubal ligation or vasectomy of the partner
(with confirmed negative sperm counts) in a monogamous relationship (same
partner). An acceptable, although less reliable method involves the careful use
of condoms and spermicidal foam or gel and/or cervical cap or sponge. We
encourage you to discuss this issue further with your doctors if you have any
questions.
Also, because the risk to young children is unknown, you should not nurse your
baby while on this study. Ask about birth control counseling and more
information about preventing pregnancy. Pregnant women and nursing mothers
are excluded from participation in this study. If a woman becomes pregnant,
she will be withdrawn from the study. If a man fathers a child, there may be
potential risk to the unborn baby; therefore, female sexual partners of men on
treatment should use an adequate form of birth control. Since most methods of
birth control are not 100% reliable, if you are a sexually active woman of
childbearing potential, a pregnancy test (at least 10 days from your last normal
menstrual period) is required.
Are There Benefits To Taking Part In The Study?
If you agree to take part in this study, there may or may not be direct medical
benefit to you. The brain irradiation may prevent cancer from spreading to the
brain, but this benefit is not guaranteed. We hope the information learned from
this study will benefit other patients with small cell lung cancer in the future.
What Other Options Are There?
You may choose to not participate in this study. Other treatments that could be
considered for your condition may include the following: (1) radiation therapy
outside this study or (2) no treatment except medications to make you feel better.
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Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
RTOG 0212
Southeast Cancer Control Consortium Consent Form
With the latter choice, your tumor could continue to grow and your disease would
spread.
Your doctor can tell you more about your condition and the possible benefits of
the different available treatments. Please talk to your regular doctor about these
and other options.
How Will Information about Me Be Kept Private?
Efforts will be made to keep your personal information confidential. We cannot
guarantee absolute confidentiality. Your personal information may be disclosed if
required by law.
12/9/03
7/8/04
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Radiation Therapy Oncology Group (RTOG)
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
Institute Gustave-Roussy
Possible other federal or state government agencies
Other groups/organizations that have a role in this study (Southwest Oncology
Group-SWOG, Eastern Cooperative Oncology Group-ECOG; and Cancer and
Leukemia Group B-CALGB)
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 lawenforcement 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?
Taking part in this study may lead to added costs to you or your insurance company.
You or your insurance carrier will be responsible for the costs of clinic visits, any
hospital admissions, laboratory tests, x-rays, scans, chemotherapy treatments, and any
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Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
RTOG 0212
Southeast Cancer Control Consortium Consent Form
other tests. Please ask your doctor about any added costs or insurance problems. You
may find a National Cancer Institute Guide: “Clinical Trials and Insurance Coverage – a
Resource Guide” helpful in this regard. You may ask your doctor for a copy, or it is
available on the world wide web at http://www.nci.nih.gov/ClinicalTrials/insurance (click
on printable version). You will not be paid to participate in this study.
In the case of injury or illness resulting from this study, emergency medical treatment is
available but will be provided at the usual charge. No funds or monies have been set
aside to compensate you in the event of injury.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
What Are My Rights as a Patient?
Taking part in this study is voluntary. 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.
8/6/03
A Data Safety and Monitoring Committee, an independent group of experts, may be
reviewing the data from this research on an ongoing basis. If any important new
information about the study develops that may affect your health, welfare, or willingness
to stay on the study, your doctor will tell you. You may be asked to sign another
consent form at that time.
Who Do I Call if I Have Questions Or Problems?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
________________________ Institutional Review Board (which is a group of people at
the hospital in the community where you receive treatment who review the research to
protect your rights) at # ______________________ (the office of _________________).
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Patient Initials _______
IRB Approval Date ______
Version Date: 12/6/05; Amendment #6
RTOG 0212
Southeast Cancer Control Consortium Consent Form
Where Can I Get More Information?
You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-4226237) or TTY: 1-800-332-8615 or you may visit the Cancer Information Service
Website: http://www.cancer.gov/cis
You may visit the NCI’s Web sites:
http://www.cancer.gov/clincial_trials
This website contains comprehensive clinical trials information.
http://www.cancer.gov/cancer_information
This website contains accurate cancer information including PDQ.
You may also call the Project Office of the NCI Central Institutional Review Board
(CIRB) at 888-549-0715 (from the continental U.S. only).
Cancer Fax
Includes NCI information about cancer treatment, screening, prevention, and
supportive care. To obtain a contents list, dial 301-402-5874 or 800-624-2511
from a fax machine hand set and follow the recorded instructions.
Patient 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.
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. A copy of this consent form has been given to me. I may also request a copy of
the study (complete study plan).
______________
(Date)
_________________________________
(Patient 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)
10/15/02
_________________________________
(Signature of Person Obtaining Consent)
Page 7 of 7
RTOG 0212
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Patient Name ______________________________________ Study/ID #___________
(Please Print Name)
Patient Signature _______________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
10/15/02
RTOG 0212
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Patient Name ______________________________________Study/ID #____________
(Please Print Name)
Patient Signature _______________________________________
Date __________
Witness Signature ______________________________________
Date __________
10/15/02