Colorectal Cancer
Conditions
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
Brief 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.
Detailed description
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.
Interventions
OTHERlaboratory biomarker analysis
PROCEDUREcomputed tomography
PROCEDUREmagnetic resonance imaging
PROCEDUREquality-of-life assessment
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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 \< 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival by intention-to-treat analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | — |
| Cost of National Health Service (NHS) services utilized | — |
| NHS cost per life-year saved | — |
Countries
United Kingdom
Outcome results
None listed