A NATIONAL COLON and Rectal CANCER
PREVENTION TRIAL Is Now Enrolling Patients
The [INSTITUTION NAME] is pleased to offer our patients access
to a national colon cancer prevention trial (SWOG S0820). The
purpose of the trial is to determine if the drug, eflornithine and
the drug, sulindac, taken alone or in combination, can prevent
the occurrence of high-risk colorectal polyps and new colorectal
cancers in patients with previously treated Stage 0-III colorectal
cancer.. People who have had colon cancer have a greater than
average risk of developing polyps in the colon and rectum,
which may become colon cancer in the future. Preventing
polyps may reduce the risk of a new colon cancer.
WHO IS ELIGIBLE TO PARTICIPATE?
The trial goal is to enroll more than 1,400 patients nationwide
who meet the following criteria:
 History of Stage 0, I, II or III colon or rectal cancer with
surgery during the previous year
 Not taking chronic anti-inflammatory medication
 Cancer free by colonoscopy and CT scans one-year
after surgery
 Completed chemotherapy at least 30 days prior to
study entry
WHAT DOES THE STUDY INVOLVE?
Patients will be assigned at random to receive one of four
treatments:
 Eflornithine 2 tablets daily plus sulindac 1 tablet daily
 Placebo for eflornithine 2 tablets daily plus sulindac 1
tablet daily
 Eflornithine 2 tablets daily plus placebo for sulindac 1
tablet daily
 Placebo for eflornithine 2 tablets daily plus placebo for
sulindac 1 tablet daily
The study drugs will be supplied free of charge and will be taken
for three years.
WHY EFLORNITHINE AND SULINDAC?
Sulindac is a nonsteroidal, anti-inflammatory pain reliever
commercially available but is not approved for this use. Oral
eflornithine is an investigational drug currently not available
outside of the clinical trial setting in the U.S. Eflornithine slows
the production of a group of naturally-formed molecules called
polyamines. Excess polyamines have a role in the development
of colorectal cancer. Sulindac helps cells get rid of excess
polyamines. Previous studies have shown that these drugs may
reduce the chances of colon polyps or the development of a
second colorectal cancer.
WHY DOES THE STUDY HAVE A PLACEBO?
A placebo is an inactive drug that has no treatment value. In
clinical trials, experimental treatments are often compared with
placebos to assess the treatment's effectiveness. The use of a
placebo is important in determining the benefits and side
effects of giving eflornithine and/or sulindac. Neither you nor
your study investigator will know whether you are taking
eflornithine, sulindac or a placebo.
HOW LONG WILL PARTICIPANTS BE IN THE STUDY?
Participants will be in the study for a total of eight years. After
three years of taking the assigned study drugs, a member of our
Cancer Research team will continue to follow-up with you every
12 months until the eighth year.
WHAT ARE THE BENEFITS OF PARTICIPATING IN CLINICAL
TRIALS?
Participating in clinical trials is voluntary. Clinical trials are
research studies that involve people. These studies test new
ways to prevent, detect, diagnose or treat diseases. Those who
choose to take part in cancer clinical trials have an opportunity
to contribute to scientists’ knowledge about cancer and to help
in the development of improved cancer treatments.
Participants also receive state-of-the-art care from cancer
experts.
CONTACT US
For more information about this trial, PACES (SWOG S0820), or
to find out about our other clinical trials, contact [INSTITUTION
NAME] at [###-###-####]. You can also get more information
about this trial or other SWOG trials at
http://swog.org/Visitors/ClinicalTrials.asp.