Metastatic Gastric Cancer FFCD 03-07

Study Overview
=================
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.

Official Title
-----------------
Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach

Conditions
-----------------
Stomach Cancer, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ECC
* Drug: FOLFIRI


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ECC | Drug: ECC<br>* capecitabine<br>|
| Experimental: 2<br>FOLFIRI | Drug: FOLFIRI<br>* Irinotecan<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, stomach cancer metastatic, Capecitabine, Irinotecan