Metastatic Gastric Cancer FFCD 03-07

Phase 3

Completed

• Conditions: Stomach Cancer; Neoplasm Metastasis
• Interventions: Drug: ECC; Drug: FOLFIRI

• Registration Number: NCT00374036
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ECC	ECC
2	FOLFIRI	FOLFIRI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France