drugset

drugset / Trial / NCT00208260

Intensified Chemotherapy in CRC After Resection of Liver Metastases

NCT00208260 ↗

Phase 2/3 Completed 124 enrolled Institut du Cancer de Montpellier - Val d'Aurelle Chugai Pharmaceutical · collab Pfizer · collab Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Timeline

Start: 2004-04
Primary completion: —
Completion: 2007-08

Publications

Results Ychou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, Letoublon C, Guimbaud R, Francois E, Ducreux M, Desseigne F, Fabre JM, Assenat E. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. The METHEP trial. Ann Surg Oncol. 2013 Dec;20(13):4289-97. doi: 10.1245/s10434-013-3217-x. Epub 2013 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	180 mg/m2	—
Subject	Irinotecan	Small molecule	260 mg/m2	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	—
Subject	Oxaliplatin	Small molecule	130 mg/m2	—
Background	CANDICIDIN	Unknown	—	—

Indications