Metastatic Gastric Cancer FFCD 03-07

This study has been completed.
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: September 6, 2006
Last updated: October 10, 2011
Last verified: October 2011

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.

Condition Intervention Phase
Stomach Cancer
Neoplasm Metastasis
Drug: ECC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time of total survival and survival without progression [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • The percentage of objective answers in first and second line [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Percentage of treated patients in second line [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Control time of the disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The tolerance, the quality of life, duration of hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 416
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: ECC
Experimental: 2

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00374036

CHU Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Principal Investigator: Rosine GUIMBAUD, MD CHU TOULOUSE
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse Identifier: NCT00374036     History of Changes
Other Study ID Numbers: 0305603
Study First Received: September 6, 2006
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
stomach cancer metastatic
stomach cancer metastatic

Additional relevant MeSH terms:
Neoplasm Metastasis
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Stomach Diseases processed this record on October 09, 2015