Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer
Phase 2
Completed
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00759226
- Lead Sponsor
- CONKO-Studiengruppe
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- Age>=18
- Histologically proven inoperable esophageal cancer
- Karnofsky Performance status >=60%
- Estimated life expectancy of > 12 weeks
- Measurable disease
- No other oncologic therapy
- Measurable disease
- Adequate bone marrow function
- Geographic proximity and compliance
- Informed consent
- Negative pregnancy test and adequate contraception
Exclusion Criteria
- Insufficient hepatic or renal function
- Elevated serum calcium
- Pregnancy/breast feeding
- Active infection
- Other malignancies
- Systemic tumour complications requiring emergency interventions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary endpoint rate of freedom of progression (PR+CR+SD). Max. 8 cycles of therapy
- Secondary Outcome Measures
Name Time Method Secondary endpoint median survival, progression free survival and toxicity. 3 years
Trial Locations
- Locations (1)
Charite Universitätsmedizin Berlin
🇩🇪Berlin, Germany