Stomach Cancer, Neoplasm Metastasis
Conditions
Keywords
chemotherapy, stomach cancer metastatic, Capecitabine, Irinotecan
Brief 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.
Detailed description
To compare the effectiveness of two different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.
Interventions
DRUGECC
capecitabine
DRUGFOLFIRI
Irinotecan
Sponsors
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Pfizer
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time of total survival and survival without progression | 3 years |
| The percentage of objective answers in first and second line | 1 year |
| Percentage of treated patients in second line | 3 years |
| Control time of the disease | 3 years |
| The tolerance, the quality of life, duration of hospitalization | 3 years |
Countries
France
Outcome results
None listed