Metastatic Gastric Cancer FFCD 03-07

Toulouse University Hospital

Status and phase

Completed

Phase 3

Conditions

Neoplasm Metastasis

Stomach Cancer

Treatments

Drug: ECC

Drug: FOLFIRI

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00374036

0305603

Details and patient eligibility

About

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.

Full 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.

Enrollment

416 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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