NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC)

Craig, Z orcid.org/0000-0001-9930-6648, Swain, J, Batman, E et al. (16 more authors) (2020) NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC). BMJ Open, 10 (2). e034527. ISSN 2044-6055

Abstract

Introduction Poorly differentiated (PD), extrapulmonary (EP), neuroendocrine carcinomas (NECs) are rare but aggressive neuroendocrine neoplasms. First-line treatment for advanced disease is an etoposide and platinum-based chemotherapy combination. There is no established second-line treatment for patients with PD-EP-NEC, and this is an area of unmet need.

Methods and analysis NET-02 is a UK, multicentre, randomised (1:1), parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive PD-EP-NEC. One hundred and two eligible participants will be randomised to receive either nal-IRI/5-FU/folinic acid or docetaxel. The primary objective is to determine the 6-month progression-free survival (PFS) rate. The secondary objectives of this study are to determine PFS, overall survival, objective response rate, toxicity, quality of life and whether neuron-specific enolase is predictive of treatment response. If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial. If both treatments meet this target, prespecified selection criteria will be applied to establish which treatment to take forward.

Ethics and dissemination This study has ethical approval from the Greater Manchester Central Research Ethics Committee (reference no. 18/NW/0031) and clinical trial authorisation from the Medicine and Healthcare Products Regulatory Agency. Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register.

Trial registration numbers ISRCTN10996604, NCT03837977, EudraCT Number: 2017-002453-11

Metadata

Item Type:	Article
Authors/Creators:	Craig, Z https://orcid.org/0000-0001-9930-6648 Swain, J Batman, E Wadsley, J Reed, N Faluyi, O Cave, J Sharma, R Chau, I Wall, L Lamarca, A Hubner, R Mansoor, W Sarker, D Meyer, T Cairns, DA https://orcid.org/0000-0002-2338-0179 Howard, H Valle, JW McNamara, MG
Copyright, Publisher and Additional Information:	© Author(s) (or their employer(s)) 2020. This is an open access article under the terms of the Creative Commons Attribution 4.0 International (CC BY 4.0) (https://creativecommons.org/licenses/by/4.0/)
Keywords:	docetaxel; liposomal irinotecan; neuroendocrine carcinoma; randomised; single-stage
Dates:	Accepted: 20 January 2020 Published (online): 5 February 2020 Published: 5 February 2020
Institution:	The University of Leeds
Academic Units:	The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds)
Funding Information:	Funder Grant number Cancer Research UK A25447 Baxalta GmbH Not Known
Depositing User:	Symplectic Publications
Date Deposited:	18 Feb 2020 15:17
Last Modified:	18 Feb 2020 15:17
Status:	Published
Publisher:	BMJ Publishing Group
Identification Number:	10.1136/bmjopen-2019-034527
Related URLs:	PubMed URL
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:157148

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