Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2005-06-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ECC
ECC
capecitabine
2
FOLFIRI
FOLFIRI
Irinotecan
Interventions
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ECC
capecitabine
FOLFIRI
Irinotecan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Roche Pharma AG
INDUSTRY
Pfizer
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Rosine GUIMBAUD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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0305603
Identifier Type: -
Identifier Source: org_study_id