follow-up study of patients who have undergone surgery for stage i, stage ii, or stage iii colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care. purpose: this randomized clinical trial is following patients who have undergone surgery for stage i, stage ii, or stage iii colorectal cancer.

objectives: primary * to assess the effect of augmenting symptomatic follow-up in primary care with two intensive methods of follow-up (monitoring tumor marker in primary care and intensive imaging in hospital) on survival of patients with stage i, ii, or iii colorectal cancer who have undergone curative resection. secondary * determine the quality of life of these patients. * determine the cost of national health service (nhs) services utilized. * determine the nhs cost per life-year saved. outline: this is a multicenter study. patients are stratified according to certainty of need for imaging follow-up, as determined by the local clinician (uncertain vs certain). patients are randomized to 1 of 4 follow-up arms. * arm i (primary care follow-up): patients undergo symptomatic follow-up (i.e., are asked to contact their physician if they have symptoms suggestive of disease recurrence). some patients may also undergo a single ct scan 12-18 months post-randomization. * arm ii (primary care follow-up): patients undergo tumor marker measurements (cea) at baseline, every 3 months for 2 years, and every 6 months for 3 years. some patients may also undergo a single ct scan 12-18 months post-randomization. * arm iii (intensive hospital follow-up): patients undergo ct scan or mri at baseline, every 6 months for 2 years, and then annually for 3 years. * arm iv (primary care and intensive hospital follow-up): patients undergo primary care and intensive hospital follow-up as in arms ii (without the single ct scan) and iii. all patients receive a handbook from their physician detailing possible symptoms suggestive of disease recurrence. quality of life is assessed at baseline and then annually for 5 years.

Eligibility criteria:
disease characteristics: * diagnosis of primary colorectal cancer * stage i-iii disease * have undergone curative resection (i.e., no residual disease \[r0\]) * microscopically clear margins * complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, ct pneumocolon, or virtual colonoscopy * post-operative blood cea ≤ 10 ng/ml (if the normal range is ≤ 5 ng/ml) or \ 5 ng/ml) * for patients undergoing adjuvant therapy, cea should be measured after completion of chemotherapy * has completed primary curative treatment, as deemed by hospital clinician * patients awaiting stoma closure allowed * no evidence of metastatic disease on pre- or post-operative liver ct scan (or ultrasound) and chest ct scan (or chest x-ray) * no diagnosis of familial adenomatous polyposis (fap) or dominantly inherited colon cancer patient characteristics: * no concurrent serious illness * history of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up prior concurrent therapy: * see disease characteristics * pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved * no concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer