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

Study Overview
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Brief Summary
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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.

Official Title
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Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Irinotecan associated to fluorouracil and leucovorin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan associated to fluorouracil and leucovorin<br>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 | Drug: Irinotecan associated to fluorouracil and leucovorin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-month Response Rate | 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.). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | From date of inclusion until the date of date of death from any cause, assessed up to 12 months. | 
| Progression-free Survival | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, gastric cancer, geriatric evaluation, efficacy, safety