Metastatic Gastric Cancer FFCD 03-07

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374036
• Other study ID #: 0305603
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2006
• Last updated: October 10, 2011
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• ECC
capecitabine
• FOLFIRI
Irinotecan

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Federation Francophone de Cancerologie Digestive, Pfizer, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time of total survival and survival without progression		3 years	Yes
Secondary	The percentage of objective answers in first and second line		1 year	Yes
Secondary	Percentage of treated patients in second line		3 years	Yes
Secondary	Control time of the disease		3 years	No
Secondary	The tolerance, the quality of life, duration of hospitalization		3 years	Yes