Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer

Phase 2

Completed

Brief Summary: The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.

The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Irinotecan associated to fluorouracil and leucovorin	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

Primary Outcome Measures

Name	Time	Method
2-month Response Rate	2 months	Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From date of inclusion until the date of date of death from any cause, assessed up to 12 months.	OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Progression-free Survival	From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months	PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Locations (6): Centre Hospitalier Universitaire de Bordeaux
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Bordeaux, France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
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Bordeaux, France
Centre Hospitalier Universitaire de Pau
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Pau, France
Clinique Francheville
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Perigueux, France
Centre Hospitalier Universitaire de Villeneuve sur Lot
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Villeneuve sur Lot, France
Hopital Robert Boulin
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Libourne, France