Metastatic Gastric Cancer FFCD 03-07

This study has been completed.
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Pfizer
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00374036
First received: September 6, 2006
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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
Drug: FOLFIRI
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
ECC
Drug: ECC
capecitabine
Experimental: 2
FOLFIRI
Drug: FOLFIRI
Irinotecan

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374036

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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov 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:
chemotherapy
stomach cancer metastatic
Capecitabine
Irinotecan
stomach cancer metastatic

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014