IRB Approval Date _______
Version Date: 1/31/06
NSABP R-04
Southeast Cancer Control Consortium Consent Form
Addendum #1
A Clinical Trial Comparing Preoperative Radiation Therapy and
Capecitabine with or without Oxaliplatin with Preoperative Radiation
Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without
Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
[This information was not provided in the original document that patients signed. It is
provided here as new information.]
New information about the NSABP R-04 study
When you joined the NSABP R-04 study, the NSABP promised to tell you of new
information about the trial.
NSABP R-04 is determining whether the use of chemotherapy pills (capecitabine) will
be as effective as chemotherapy (5-FU) given intravenously with an infusion pump
when combined with radiation therapy. The researchers responsible for the R-04 study
have decided that an additional question about another chemotherapy drug should be
asked in this study. The chemotherapy drug, oxaliplatin, has been added to the study to
see if oxaliplatin when given with capecitabine or 5-FU can improve how well these
drugs work. In the future, patients who join the R-04 study will be assigned to 1 of 4
treatment groups. Two of the treatment groups are like the treatments you were told
about when you joined the study. The 2 new treatments include oxaliplatin. This new
study question does not affect your R-04 study therapy because you are already
receiving your study therapy or you have already completed it. No proven therapy is
being withheld from you because there is no evidence from clinical trials that oxaliplatin
will be effective when combined with the other drugs and radiation therapy given before
surgery as part of the R-04 study.
New information about your R-04 follow-up care after surgery
When you joined the study, you were told that your study doctor would follow your
health for the rest of your life. Your study doctor will now follow your health for only 5
years after your surgery. This change was made because the researchers have
decided that the information collected from patients for 5 years will be enough to answer
the study questions.
There are also changes to your follow-up tests and exams.
 You were told you would have a physical examination every 3 months for the first 2
years, and then, every 6 months for the next 3 years. You will now only need to have
a physical examination every 6 months for 5 years.
1/31/06
Page 1 of 2
Participant Initials ____
IRB Approval Date _______
Version Date: 1/31/06
NSABP R-04
Southeast Cancer Control Consortium Consent Form
Addendum #1
 You were told that you would possibly have blood tests once a year for 5 years. Now
you will have blood tests every 6 months for 5 years.
 Instead of having an exam of your entire colon (colonoscopy) at 1 and 2 years after
your surgery, you will have a colonoscopy only at 1 year after your surgery. Also, at
2 and 3 years after your surgery, you will have an exam that just looks at your lower
colon and the area of your rectum where your tumor had been. This exam is called a
proctoscopy or sigmoidoscopy.
 Instead of having a CT scan or MRI of your abdomen and pelvis once every year for
5 years you will now have CT or MRI scans at 1 and 2 years after surgery.
These follow-up tests and exams are part of regular cancer care except for the
proctocoscopy or sigmoidoscopy done at years 2 and 3, which are being done for study
purposes only and will be paid for by the study.
You should discuss these changes with your study doctor ____________________ at
phone # ________________________. Your doctor may require additional tests to be
done that are not required by the study if it is in your best interest.
Signatures
I have read this consent form or it has been read to me. I understand the new
information and have had my questions answered. A copy of this form has been
provided to me.
________________________
Date
_______________________________________
Participant Signature
____
Date
1/31/06
__
Signature of Person Conducting
the Informed Consent Discussion
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