Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments diagnostic laboratory biomarker analysis, computed tomography, diagnostic colonoscopy, standard follow-up care, ultrasound imaging
Phase phase 3
Sponsor Federation Francophone de Cancerologie Digestive
Start date September 2009
End date April 2018
Trial size 1997 participants
Trial identifier NCT00995202, 2009-A00536-51, CDR0000654114, EU-20979, FFCD-PRODIGE-13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Sham Comparator)
In the standard monitoring arm, abdominal ultrasound examination is performed every 3 months for 3 years, then every 6 months for 2 years, then annually. A Chest X-ray is performed every 6 months for 3 years then annually for 2 years.
diagnostic laboratory biomarker analysis
computed tomography
diagnostic colonoscopy
standard follow-up care
(Experimental)
A thoraco-abdominal-pelvic CT scan alternating with abdominal ultrasound is performed every 3 months for 3 years, then every 6 months for 2 years. CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
diagnostic laboratory biomarker analysis
computed tomography
diagnostic colonoscopy
ultrasound imaging

Primary Outcomes

Measure
Overall survival rate
time frame: 5 years

Secondary Outcomes

Measure
Disease-free survival rate
time frame: 5 years
Cost-effectiveness study
time frame: 5 years
Quality of life
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Principal investigator Come Lepage, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive.