Metastatic Gastric Cancer FFCD 03-07

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00374036
• Date of registration: 06/09/2006
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Metastatic Gastric Cancer FFCD 03-07
• Scientific title: Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach
• Date of first enrolment: June 2005
• Target sample size: 416
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00374036
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Rosine GUIMBAUD, MD
• Affiliation: CHU TOULOUSE

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasm Metastasis

Stomach Cancer

Intervention(s)

Drug: FOLFIRI

Drug: ECC

Primary Outcome(s)

Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line [Time Frame: 20 weeks]

Secondary Outcome(s)

The tolerance, the quality of life, duration of hospitalization [Time Frame: 3 years]

Control time of the disease [Time Frame: 3 years]

Percentage of treated patients in second line [Time Frame: 3 years]

Time of total survival and survival without progression [Time Frame: 3 years]

The percentage of objective answers in first and second line [Time Frame: 1 year]

Secondary ID(s)

0305603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Federation Francophone de Cancerologie Digestive

Roche Pharma AG

Pfizer