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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00560365
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 19, 2007
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date November 16, 2007
First Posted Date November 19, 2007
Last Update Posted Date August 8, 2011
Study Start Date March 2004
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 16, 2007)
Overall survival by intention-to-treat analysis
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 16, 2007)
  • Quality of life
  • Cost of National Health Service (NHS) services utilized
  • NHS cost per life-year saved
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Colorectal Cancer
Intervention
  • Other: laboratory biomarker analysis
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 16, 2007)
4760
Original Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00560365
Other Study ID Numbers CDR0000576476
USCTU-FACS
ISRCTN41458548
EU-20788
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators Not Provided
Investigators
Study Chair: John N. Primrose, MD University Hospital Southampton NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date August 2009