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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)


N/A
50 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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)


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Overall survival by intention-to-treat analysis

Safety Issue:

No

Principal Investigator

John N. Primrose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Southampton NHS Foundation Trust.

Authority:

Unspecified

Study ID:

CDR0000576476

NCT ID:

NCT00560365

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • Colorectal Neoplasms

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