Phase II randomized trial comparing 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP) in metastatic gastric, pancreatic and oesophageal cancer
- Conditions
- Metastatic gastric, pancreatic and oesophageal cancerCancerOesophageal
- Registration Number
- ISRCTN05842222
- Lead Sponsor
- French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 232
Histologically proven carcinoma of the oesophagus, the stomach or the pancreas, with a measurable metastatic disease (=15 mm) and without indication of radiotherapy and/or surgery; no prior chemotherapy for metastatic disease and, in case of adjuvant chemotherapy, no regimen containing cisplatin; age =75 years and World Health Organization (WHO) performance status <2; adequate baseline organ function, defined as neutrophile count =1500/mm^3, platelet count =100,000/mm^3 and creatinine level <1.25 normal level; in case of patient older than 70 years and/or creatinine level between 1 and 1.25 normal limit, creatinine clearance had to be more than 60 ml/mm; and written informed consent approved by the local Ethical Committee was given by all the participants before they entered the study.
Severe uncontrolled co-morbidities, brain metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Clinical efficacy and quality of life