Status:
COMPLETED
Metastatic Gastric Cancer FFCD 03-07
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Conditions:
Stomach Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 metastat...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00374036
Start Date
June 1 2005
End Date
December 1 2009
Last Update
October 12 2011
Active Locations (1)
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1
CHU Toulouse
Toulouse, France