Clinical trial · Interventional
Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive Monitoring CEA | Procedure | — | UNRESOLVED |
| Intensive Monitoring Imagery | Procedure | — | UNRESOLVED |
| Standard Monitoring CEA | Procedure | — | UNRESOLVED |
| Standard Monitoring Imagery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Standard Monitoring CEA/ Standard Imagery
- description
- No specific follow-up of CEA and Standard imagery
- interventionNames
- Procedure: Standard Monitoring CEA
- Procedure: Standard Monitoring Imagery
- type
- OTHER
- label
- Intensive monitoring CEA/ Standard Imagery
- description
- Intensive follow-up CEA and Standard imagery .
- interventionNames
- Procedure: Intensive Monitoring CEA
- Procedure: Standard Monitoring Imagery
- type
- OTHER
- label
- Intensive Monitoring CEA / Intensive Monitoring Imagery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLepage C, Phelip JM, Cany L, Faroux R, Manfredi S, Ain JF, Pezet D, Baconnier M, Deguiral P, Terrebone E, Adenis A, Le Malicot K, Bedenne L, Bouche O. Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer: The FFCD PRODIGE 13 randomised phase III trial. Dig Liver Dis. 2015 Jul;47(7):529-31. doi: 10.1016/j.dld.2015.03.021. Epub 2015 Apr 2. No abstract available. PMID 25933809
- DERIVEDLecuelle J, Truntzer C, Basile D, Laghi L, Greco L, Ilie A, Rageot D, Huppe T, Emile JF, Bibeau F, Taieb J, Derangere V, Lepage C, Ghiringhelli F. Deep learning based on CD3 histological slides for prediction of colon cancer outcome: analysis of three international stage III colon cancer cohorts. Oncoimmunology. 2026 Dec 31;15(1):2668797. doi: 10.1080/2162402X.2026.2668797. Epub 2026 May 8. PMID 42100890