NCT00759226

Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer

An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: CONKO-Studiengruppe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 (30 min)
DRUG	Cisplatin	Cisplatin 30 mg/m2 (90 min)
DRUG	5-FU	5-FU 750 mg/m2 (24h CI)
DRUG	Folinic Acid	Folinic Acid 200 mg/m2 (30 min)

Timeline

• Start date: 2002-07-01
• Primary completion: 2005-07-01
• Completion: 2007-08-01
• First posted: 2008-09-25
• Last updated: 2008-09-26

Locations

1 site across 1 country: Germany