Metastatic Gastric Cancer FFCD 03-07

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Federation Francophone de Cancerologie Digestive; Pfizer; Roche Pharma AG

Criteria

Inclusion Criteria:

• age = 18 years old

• patients carrying a adenocarcinoma of the stomach or cardia histologically proven

• locally advanced tumour which may not be treated surgically or metastatic tumour

• the patients having a stenosante tumour responsible for a disphagy had to have a tumoral ablation or a prosthesis or a probe of food,

• measurable lesions according to criteria RECIST (specify measurement by spiral scanner of largest diameter of with less the one lesion of size higher than 1 cm) or appraisable but nonmeasurable (lesions < 1 cm, ascite, pleural effusion...)

• general state WHO < 2

• absence of insufficiency cardiac or coronary symptomatic

• absence of previous chemotherapy other that auxiliary stopped since more than 6 months

• filled questionnaires QLQ C30 and STO-22

• PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3

• creatinin ≤ 110 micromol/l

• bilirubin ≤ 35 micromol/l

Exclusion Criteria:

• disphagy or intestinal obstruction incompatible with a treatment per os or by a probe of food

• pregnant or nursing woman

• previous of cardiac toxicity to the 5FU or to the anthracyclines

• radiotherapy less than 3 weeks before inclusion, whatever the site

• other evolutionary cancer threatening the short-term life

• metastasis cerebral or méningée known (without obligation to seek it)

• impossibility of regular follow-up for psychological, social, family or geographical reasons