Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00995202
First received: October 14, 2009
Last updated: October 16, 2009
Last verified: October 2009
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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 3 |
| 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:
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) |
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:
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 May 21, 2013