Metastatic Gastric Cancer FFCD 03-07
This study has been completed.
Sponsor:
University Hospital, Toulouse
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
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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
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 May 22, 2013