SWOG Study S0820 Page
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.
More information about the study?
- 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.
- Participants can find a comprehensive list of locations, including non-SWOG locations, where this trial is open 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 Jennifer Maeser: wraavsrez/ng/peno/qbg/bet.
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.
- S0820 Patient Brochure for Sites to Add Their Contact Information and Printing Instructions (PDF) - Please read these instructions for adding contact information and printing the brochure: Brochure Instructions
- Promotional Flyer (DOC): Add your contact information to the Flyer. You can use this as a handout for patients or to post in clinics or waiting areas.
- Spanish-language patient materials: The document linked below is a certified translation of the English-language document.
- Spanish-language version of the thank you letter to enrollees from Dr. Zell
Staff Training Information
- S0820 Webinar for Study Sites: An extended FAQ from our April 16th webinar will be posted to the S0820 resource page in May. -->
- FAQs for Staff and Investigators (PDF)
- Staff Newsletter, August 2017 (PDF)
General Recruitment Strategies and Materials
- Professional Slide Set (PPTX)
- Recruitment Strategies (PDF)
- Notification of Patient Registration Letter to Local Physician (DOC)
- Study Logo and Instructions for Printing
Adherence Strategies and Information
- Welcome to S0820 Folder (PDF)
- Thank you letter to enrollees from Dr. Zell (PDF)
- Thank you letter to enrollees from institution PI (DOC) [Spanish-language version]
- Promoting Adherence Strategies (PDF)
- Warning Signs of Poor Adherence (PDF)
- Printable birthday card selections