Status:
COMPLETED
Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer
Lead Sponsor:
CONKO-Studiengruppe
Collaborating Sponsors:
Eli Lilly and Company
medac GmbH
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
Eligibility Criteria
Inclusion
- 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
- Insufficient hepatic or renal function
- Elevated serum calcium
- Pregnancy/breast feeding
- Active infection
- Other malignancies
- Systemic tumour complications requiring emergency interventions
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00759226
Start Date
July 1 2002
End Date
August 1 2007
Last Update
September 26 2008
Active Locations (1)
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1
Charite Universitätsmedizin Berlin
Berlin, Germany, 13353