Clinical trial · Interventional
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
NCT00189657CI-TRIAL-00000165unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.
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 |
|---|---|---|---|
| Cancer of the Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5FU/LV Mayo Clinic or LV5FU2 | Procedure | — | UNRESOLVED |
| LV5FU2 + irinotecan | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * rectal adenocarcinoma * R0 surgery * T3, N0, M0 or T4, N0, M0 or N1,2, M0 * chemotherapy can be started within 8 weeks after surgery * Age \> 18 * Performance status ECOG \< 3 * preoperative radiotherapy allowed * preoperative chemotherapy with 5FU +/- LV allowed * Neutrophiles \> 1 500/mm3; Pl. \> 100 000/mm3 * Transaminases \< 2 x UNL; Alcalines Phosphatases \< 2 x UNL; Bili \< 1.1 UNL * creatininemia \< 120 µmol/l and/or clearance of creatininemia \> 60 ml/mn * Written informed consent before inclusion Exclusion Criteria: * postoperative radiotherapy * Distant metastases * Contraindication to any drug contained in the chemotherapy regimens * Any serious active disease or co-morbid medical condition including digestive inflammatory disease * Gilbert disease * severe toxicity of radiotherapy * Pregnancy or breast feeding * Absence of contraception in non menopausal women * Adult patient unable to give informed consent because of intellectual impairment * Concomitant participation to another trial
References
Publications (0)
Data not yet available
No reference posted for this study.