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Metastatic Gastric Cancer FFCD 03-07

Primary Purpose

Stomach Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ECC
FOLFIRI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring chemotherapy, stomach cancer metastatic, Capecitabine, Irinotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

ECC

FOLFIRI

Outcomes

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

Secondary Outcome Measures

Time of total survival and survival without progression
The percentage of objective answers in first and second line
Percentage of treated patients in second line
Control time of the disease
The tolerance, the quality of life, duration of hospitalization

Full Information

First Posted
September 6, 2006
Last Updated
October 10, 2011
Sponsor
University Hospital, Toulouse
Collaborators
Federation Francophone de Cancerologie Digestive, Roche Pharma AG, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00374036
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Federation Francophone de Cancerologie Digestive, Roche Pharma AG, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer, Neoplasm Metastasis
Keywords
chemotherapy, stomach cancer metastatic, Capecitabine, Irinotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ECC
Arm Title
2
Arm Type
Experimental
Arm Description
FOLFIRI
Intervention Type
Drug
Intervention Name(s)
ECC
Intervention Description
capecitabine
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
Irinotecan
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time of total survival and survival without progression
Time Frame
3 years
Title
The percentage of objective answers in first and second line
Time Frame
1 year
Title
Percentage of treated patients in second line
Time Frame
3 years
Title
Control time of the disease
Time Frame
3 years
Title
The tolerance, the quality of life, duration of hospitalization
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosine GUIMBAUD, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25287828
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. Erratum In: J Clin Oncol. 2015 Apr 20;33(12):1416.
Results Reference
derived

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Metastatic Gastric Cancer FFCD 03-07

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