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Follow-Up Study of Patients W...

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

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Colorectal Cancer

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

computed tomography

Intervention Type PROCEDURE

magnetic resonance imaging

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers