Research & Trial Information
Protocol#: SWOG – S0820
Cancer Type: Cancer Control & Prevention/Colorectal
- Patients must have a history of Stage 0, I, II or 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.
- Patients 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 (EMR). 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.• Clear margins
• None of the following must be present: o Moderate or poor differentiation
o Lymphovascular invasion
o Perineural invasion
- Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if NCCN criteria for transanal excision are met.
- 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 postoperative colonoscopy are eligible if all adenomas have been completely removed.
- Patients must be at least 18 years of age.
- Patients must have a Zubrod Performance Status of 0 – 1.
- Patients must not be expecting to receive radiation or additional chemotherapy.
- 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 or predictable intermittent basis. (NSAID use may not exceed 10 days per month.) Patients may receive daily aspirin for cardiovascular prophylaxis as long as ASA is ≤ 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.