This page is for reference and assistance to study sites participating in SWOG's clinical trial S0820, "A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer." This study is also known as the PACES study, short for "Preventing Adenomas of the Colon with Eflornithine & Sulindac."
Why is this study being done?
Colorectal adenomas are tiny growths in the colon that may eventually lead to cancer. The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. ("Second primary colorectal cancer" means a new colorectal cancer developing within the colorectum.)
The study drugs eflornithine and sulindac are tablets which are taken orally. Sulindac is commercially available but is not approved for this indication. Oral eflornithine is an investigational agent and not approved by the FDA.
Members version of the protocol abstract page (from which the full protocol is available): S0820 Protocol Abstract Page. Staff from non-SWOG sites can find the full protocol and related materials by logging in to the CTSU site.
For general questions about the study, select "Protocols" as the subject area on the Contact Us page and we will get in touch with you.
Prospective participants in the study can find contact information for the site nearest them by clicking the "Where is this study open" button at the bottom of the Protocol Abstract page. Participants can find a more comprehensive list of locations, including non-SWOG locations, in the "Contacts and Locations" section of ClinicalTrials.gov S0820 page.
S0820 PACES Video: Preventing Recurrent Colon or Rectal Cancer/PACES
Training, Recruitment and Adherence Materials
If you have suggestions for newsletter content, please contact Karen Anderson email@example.com.
Materials for Patients
Please use the patient handouts below as needed. Your institution must obtain local IRB approval prior to distributing these handouts to patients.
Carefully review each document you plan to use and fill in or delete any italicized text. Use the PACES logo whenever possible on the documents. There are a variety of logo file types available, i.e., TIFF, JPEG, black and white, color,etc., in the document titled Study Logo and Instructions for Printing.