Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
This multicenter open labeled phase 2 trial examines the efficacy of a combination of
Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min)
and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal
cancer. The combination was considered to be suitable for further evaluation with a freedom
of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate
of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable
patients were needed based on a 2-Stage Simon design with a first evaluation after 25
evaluable patients.