5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00189657
Recruitment Status : Unknown
Verified September 2005 by Association Européenne de Recherche en Oncologie. Recruitment status was: Recruiting
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.
Condition or disease
Cancer of the Rectum
Procedure: 5FU/LV Mayo Clinic or LV5FU2Procedure: LV5FU2 + irinotecan
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
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