Phase III 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 or Rectal Cancers

April 9, 2020

PROTOCOL: SWOG-S0820

SCHEMA S0820

Please Note: Below is partial eligibility, for full eligibility requirements, please contact GHCI research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!

ELIGIBILITY:

  1. Patients must have a history of Stage 0-III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy. Adjuvant chemotherapy and RT treatment must have been completed at least 30 days prior to registration.
  2. Patient with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection).  The definition of resection does not include endomucosal resection.  Patients that have received total proctocolectomy are ineligible. In addition to segmental resections, the following types of procedures are allowed:                        Polypectomy: For Tis (Stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met: • Single specimen, completely removed. • Negative margins of resection • Grade 1 or 2 • No angiolymphatic invasion        Transanal local excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if NCCN criteria for transanal excision are met,
    as stipulated here:  NCCN Criteria for Transanal excision:    • <3 cm in size  • T1  • Grade 1 or 2  • No lymphatic or venous invasion • Negative margin  • Sm3 depth of tumor invasion is not allowed    When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used. TEM for more proximal lesions may be technically feasible.
  3. Patients must be registered between 120 days and 456 days (inclusive) of primary resection. Patients must show no evidence of colorectal cancer based on post-operative colonoscopy (performed at least 120 days after the colon or rectal resection date and prior to registration). Patients with adenomas detected at the one-year post-operative colonoscopy are eligible if all adenomas have been completely removed.
  4. Patients must be at least 18 years of age.
  5. Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, inflammatory bowel disease, biallelic mismatch repair deficiency syndrome, or constitutional mismatch repair deficiency syndrome.
  6. Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration.  Note: No order for audiometry evaluation should be scheduled until the potential participant has met all other eligibility criteria required for this study.
  7. Zubrod Performance Status 0-1.
  8. Patients must not be expecting to receive radiation or additional chemotherapy.
  9. Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDS), nor anticoagulants on a regular basis.
  10. Patients must have the ability to swallow pills.
  11. Patients with prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

 

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