Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00995202
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2009-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Study Overview
Official Title:
Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURVEILLANCE
Brief 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.
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: