Evidence map›Paper›PMID 32690499›Full record

ArticleBMJ open2020

Randomised 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.

Alberto Bongiovanni, Chiara Liverani, Sara Pusceddu, Silvana Leo, Giovanni Di Meglio, Stefano Tamberi, Daniele Santini, Fabio Gelsomino, Francesca Pucci, Rossana Berardi and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03387592 (A Randomized Phase II Trial of Capecitabine and Temozolomide), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03387592 phase2terminatednot on this map

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

TypeinterventionalSponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSRan2017 to 2022Enrolled53ConditionsNeuroendocrine CarcinomaArmsCPT-11, Calcio levofolinate, 5-Fluorouracil, Capecitabine, Temozolomide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

  1. Phase II Study of ONC201 in Neuroendocrine Tumors including Pheochromocytoma-Paraganglioma and Desmoplastic Small Round Cell Tumor.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 1 country.

Alberto BongiovanniOsteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy alberto.bongiovanni@irst.emr.it.ORCID 0000-0002-3845-4687
Chiara LiveraniOsteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Sara PuscedduDepartment of Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Lombardia, Italy.
Silvana LeoOncology Unit, Ospedale Vito Fazzi, Lecce, Puglia, Italy.
Giovanni Di MeglioOncology Unit, Ospedale di Bolzano, Bolzano, Trentino-Alto Adige, Italy.
Stefano TamberiOncology Unit, Ospedale degli Infermi di Faenza, Faenza, Emilia-Romagna, Italy.
Daniele SantiniDepartment of Medical Oncology, Campus Bio-Medico University, Roma, Lazio, Italy.
Fabio GelsominoDepartment of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Emilia-Romagna, Italy.
Francesca PucciMedical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.
Rossana BerardiOncology Clinic, University Hospital of Ancona Umberto I G M Lancisi G Salesi, Ancona, Marche, Italy.
Ivan LolliDepartment of Oncology, Istituto Nazionale di Ricovero e Cura a Carattere Scientifico Saverio de Bellis, Castellana Grotte, Puglia, Italy.
Francesca BergamoDepartment of Clinical and Experimental Oncology, Istituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Veneto, Italy.
Sergio RicciInternal Medicine and Medical Oncology, Santa Chiara Hospital, Pisa, Toscana, Italy.
Flavia FocaUnit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Stefano SeveriNuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Toni IbrahimOsteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
SENECA Study Team Investigators
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITAzienda Ospedaliero-Universitaria di Modena · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITGastroenterology Hospital "Saverio de Bellis" · ITIstituto Oncologico Veneto · ITOspedale degli Infermi · ITOspedale di Bolzano · ITOspedale di Parma · ITOspedale Santa Chiara · ITOspedale Vito Fazzi · ITOspedali Riuniti Umberto I · ITUniversità Campus Bio-Medico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients 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. METHODS AND ANALYSIS: 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. Secondary aims are to correlate the serum miRNA profile and primary mutational status of MEN1, DAXX, ATRX and RB-1 with prognosis and outcome and to investigate the prognostic and predictive role of the Ki-67 score and 18-fluorodeoxyglucose positron emission tomography/computed tomography ( ETHICS AND DISSEMINATION: The SENECA trial, supported by Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), was authorised by the locals Ethics Committee and the Italian Medicines Agency (AIFA). Results will be widely disseminated via peer-reviewed manuscripts, conference presentations and reports to relevant authorities.The study is currently open in Italy. TRAIL REGISTRATION NUMBER: NCT03387592; Pre-results. EudraCT-2016-000767-17. PROTOCOL VERSION: Clinical Study Protocol Version 1, 7 November 2016.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkersCapecitabineCarcinoma, NeuroendocrineClinical Trials as TopicFluorouracilGastrointestinal NeoplasmsHumansIrinotecanItalyLeucovorinLung NeoplasmsMicroRNAsMulticenter Studies as TopicPancreatic NeoplasmsPositron Emission Tomography Computed TomographyBiomarkersCapecitabineFluorouracilIrinotecanLeucovorinMicroRNAsTemozolomidecapecitabine, temozolomideCAPTEMFOLFIRIneuroendocrine carcinomasecond-line

Identifiers

PMID32690499
PMCPMC7371236
OpenAlexW3043209947

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.