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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00189657
Study type Interventional
Source Association Européenne de Recherche en Oncologie
Contact Annie JOUHAUD
Phone + 33 1 43 77 72 10
Email annie.jouhaud@aero-eu.org
Status Recruiting
Phase Phase 3

See also
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Terminated NCT04150705 - PET/MR for Rectal Cancer Treatment Monitoring and Surveillance N/A
Active, not recruiting NCT05179837 - Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps N/A
Completed NCT02017509 - Immunoscore in Rectal Cancer
Active, not recruiting NCT01804790 - Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer Phase 3