Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer - Full Text View

Sponsor:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00995202

Purpose

RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Other: diagnostic laboratory biomarker analysis Procedure: computed tomography Procedure: diagnostic colonoscopy Procedure: standard follow-up care Procedure: ultrasound imaging	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Colonoscopy Colorectal Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Increase of 5% of the 5-year overall survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival rate [ Designated as safety issue: No ]
Curative resection rate in case of recurrence [ Designated as safety issue: No ]
5-year overall survival rate [ Designated as safety issue: No ]
Cost-effectiveness study [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	1925
Study Start Date:	September 2009
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.

OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.

Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.

Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.

CEA measurement: Patients undergo measurement of CEA levels every 3 months until year 3, every 6 months until year 5, and at least yearly thereafter.
No CEA measurement: Patients do not undergo CEA measurement. Blood and tissue blocks of normal and tumor tissues are collected for the validation of protein serum, genetics, or immunologic markers predictive for relapse.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed adenocarcinoma of the colon or rectum
- Stage II or III disease
- No distant metastatic disease
Has undergone curative resection for no residual tumor
Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Not pregnant or nursing
Fertile patients must use effective contraception
No inflammatory bowel disease
No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
No genetic syndromes

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995202

Locations

France
Federation Francophone de Cancerologie Digestive	Recruiting
Dijon, France, 21079
Contact: Come Lepage, MD 33-380-393-340

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

Principal Investigator:

Come Lepage, MD

Centre Hospitalier Universitaire de Dijon

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00995202 History of Changes
Other Study ID Numbers:	CDR0000654114, FFCD-PRODIGE-13, 2009-A00536-51, EU-20979
Study First Received:	October 14, 2009
Last Updated:	October 16, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II colon cancer
stage II rectal cancer
stage III colon cancer

stage III rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 09, 2012