Metastatic Gastric Cancer FFCD 03-07

Phase 3 Completed 416 enrolled University Hospital, Toulouse Federation Francophone de Cancerologie Digestive · collab Pfizer · collab Roche Pharma AG · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.

Timeline

Start: 2005-06
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

paper median TTF was significantly longer with FOLFIRI than with ECX (5.1 v 4.2 months; P = .008). PMID 25287828 ↗

Publications

Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, Andre T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouche O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	—	—
Subject	Irinotecan	Small molecule	—	—