biostudies-literatureUnknown10(7)Bongiovanni A<h4>Introduction</h4>Patients with metastatic or locally advanced, non-resectable, grade 3 poorly differentiated gastroenteropancreatic (GEP) and lung neuroendocrine carcinomas (NECs) are usually treated with in first-line platinum compounds. There is no standard second-line treatment on progression. Accurate biomarkers are needed to facilitate diagnosis and prognostic assessment of patients with NEC.<h4>Methods and analysis</h4>The SEcond-line therapy in NEuroendocrine CArcinomas (SENECA) study is a randomised, non-comparative, multicentre phase II trial designed to evaluate the efficacy and safety of folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) or capecitabine plus temozolomide (CAPTEM) regimens after failure of first-line chemotherapy in patients with lung NEC and GEP-NEC. SecoBMJ opene034393https://www.ebi.ac.uk/biostudies/studies/S-EPMC7371236biostudies-literatureRandomised phase II trial of CAPTEM or FOLFIRI as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET/CT imaging and biological markers (SENECA trial): a study protocol.PMC7371236Santini DRicci SBongiovanni ALiverani CPastorelli DFoca FPucci FBuonadonna ACives MBadalamenti GCingarlini SCampana DBrizzi MPSilvestris NBergamo FTamberi SAntonuzzo LDi Meglio GLolli IBerardi RPusceddu SSpada FGelsomino FIbrahim TLeo SBerruti ASENECA Study Team InvestigatorsSeveri SfalseRandomised phase II trial of CAPTEM or FOLFIRI as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET/CT imaging and biological markers (SENECA trial): a study protocol.<h4>Introduction</h4>Patients with metastatic or locally advanced, non-resectable, grade 3 poorly differentiated gastroenteropancreatic (GEP) and lung neuroendocrine carcinomas (NECs) are usually treated with in first-line platinum compounds. There is no standard second-line treatment on progression. Accurate biomarkers are needed to facilitate diagnosis and prognostic assessment of patients with NEC.<h4>Methods and analysis</h4>The SEcond-line therapy in NEuroendocrine CArcinomas (SENECA) study is a randomised, non-comparative, multicentre phase II trial designed to evaluate the efficacy and safety of folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) or capecitabine plus temozolomide (CAPTEM) regimens after failure of first-line chemotherapy in patients with lung NEC and GEP-NEC. Seco2020-01-01T00:00:00Z2020 Jul2026-04-12T16:11:48.82Z2020-11-19T08:16:28ZS-EPMC73712363269049910.1136/bmjopen-2019-034393