Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary endpoint rate of freedom of progression (PR+CR+SD).
Outcome Time Frame:
Max. 8 cycles of therapy
Safety Issue:
No
Principal Investigator
Hanno Riess, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Charite Universitätsmedizin Berlin
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CONKO-101
NCT ID:
NCT00759226
Start Date:
July 2002
Completion Date:
August 2007
Related Keywords:
- Esophageal Cancer
- esophageal cancer
- Gemcitabine
- Cisplatin
- 5-FU
- Folinic Acid
- inoperable esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms