Spots Global Cancer Trial Database for CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

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Trial Identification

Brief Title: CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

Official Title: A Randomized Phase II Trial of Capecitabine and Temozolomide (CAPTEM) or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas and Exploratory Analysis of Predictive Role of Positron Emission Tomography (PET) Imaging and Biological Markers

Study ID: NCT03387592

Conditions

Neuroendocrine Carcinoma

Interventions

Study Description

Brief Summary: This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.

Detailed Description: This is a multicenter randomized phase II non comparative study. Patients with metastatic NEC G3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment The primary objective is to assess DCR and the safety as co-primary objective. The secondary objectives are: OS, PFS, quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose. The secondary exploratory objectives are the assessment of the impact of PET with gallium on PFS and the evaluation of biomarkers Study treatment: FOLFIRI regimen * Oxaliplatin (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by * Calcio levofolinate 200 mg/m2, given as a 2h i.v. infusion on days 1 every 2 weeks followed by * 5-Fluorouracil 400 mg/m2 given as bolus, and then 5-Fluorouracil 2400 mg/m2 given as a 48 h continuous infusion on day 1, every 2 weeks, until progression or for a maximum of 12 cycles CAPTEM regimen Capecitabine 750 mg/m2 twice a day on days 1-14 in combination with temozolomide 200 mg/m2 daily on days 10-14, every 4 weeks, until progression or for a maximum of 6 cycles.