Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer

A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)

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.

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 < 2 times upper limit of normal (if normal range is > 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