Clinical trial NCT00374036: Metastatic Gastric Cancer FFCD 03-07
Official title: Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Cancer
Neoplasm Metastasis
Keywords: chemotherapy
stomach cancer metastatic
Capecitabine
Irinotecan
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Federation Francophone de Cancerologie Digestive
name: Roche Pharma AG
name: Pfizer
First posted: 2006-09-08
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line
timeFrame: 20 weeks
Secondary outcomes:
measure: Time of total survival and survival without progression
timeFrame: 3 years
measure: The percentage of objective answers in first and second line
timeFrame: 1 year
measure: Percentage of treated patients in second line
timeFrame: 3 years
measure: Control time of the disease
timeFrame: 3 years
measure: The tolerance, the quality of life, duration of hospitalization
timeFrame: 3 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Rosine GUIMBAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, Andre T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouche O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6.