Clinical trial NCT00560365: Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-19
Enrollment: 4760
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 \< 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

Primary outcomes:
measure: Overall survival by intention-to-treat analysis
Secondary outcomes:
measure: Quality of life
measure: Cost of National Health Service (NHS) services utilized
measure: NHS cost per life-year saved
Other outcomes:
Locations:
city: Burton-upon-Trent
country: United Kingdom
facility: Queen's Hospital
state: England
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: England
city: Chichester
country: United Kingdom
facility: Saint Richards Hospital
state: England
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital
state: England
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: England
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals Trust- Leighton Hopsital
state: England
city: Croydon
country: United Kingdom
facility: Mayday University Hospital
state: England
city: Dartford Kent
country: United Kingdom
facility: Darent Valley Hospital
state: England
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: England
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: England
city: Grantham, Lincolnshire
country: United Kingdom
facility: Grantham and District Hospital
state: England
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: England
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital
state: England
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
state: England
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
state: England
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Maidstone
country: United Kingdom
facility: Mid Kent Oncology Centre at Maidstone Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: England
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: England
city: Slough, Berkshire
country: United Kingdom
facility: Wexham Park Hospital
state: England
city: Solihull
country: United Kingdom
facility: Solihull Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Surrey
country: United Kingdom
facility: St. Peter's Hospital
state: England
city: Truro, Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: Warrington
country: United Kingdom
facility: Warrington Hospital NHS Trust
state: England
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
state: England
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: John N. Primrose, MD
role: STUDY_CHAIR
References: