Metastatic gastric, pancreatic and oesophageal cancer Cancer Oesophageal
Conditions
Interventions
First line chemotherapy - 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP)
Sponsors
French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Severe uncontrolled co-morbidities, brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy and quality of life | — |
Countries
France
Outcome results
None listed