Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer (CEPAFIRI)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Chemotherapy, gastric cancer, geriatric evaluation, efficacy, safety
Eligibility Criteria
Inclusion Criteria: 70 years of age or older Gastric cancer, locally advanced or metastatic No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months One measurable lesion ECOG < 3 Biology and biochemistry within normal limits Life expectancy > 12 weeks Exclusion Criteria: Other palliative chemotherapy for this cancer Other cancer in the last 5 years Previous treatment with irinotecan Atropine treatment not possible Concomitant cancer therapy except bone radiotherapy Metastases to brain or meninges with symptoms Other severe pathology uncontrolled Problem of compliance
Sites / Locations
- Centre Hospitalier Universitaire de Bordeaux
- Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
- Hopital Robert Boulin
- Centre Hospitalier Universitaire de Pau
- Clinique Francheville
- Centre Hospitalier Universitaire de Villeneuve sur Lot
Arms of the Study
Arm 1
Experimental
Irinotecan associated to fluorouracil and leucovorin
On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity. Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration. Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months