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@article{Craig:2020:10.1136/bmjopen-2019-034527,
author = {Craig, Z and Swain, J and Batman, E and Wadsley, J and Reed, N and Faluyi, O and Cave, J and Sharma, R and Chau, I and Wall, L and Lamarca, A and Hubner, R and Mansoor, W and Sarker, D and Meyer, T and Cairns, DA and Howard, H and Valle, JW and McNamara, MG},
doi = {10.1136/bmjopen-2019-034527},
journal = {BMJ Open},
pages = {e034527--e034527},
title = {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).},
url = {http://dx.doi.org/10.1136/bmjopen-2019-034527},
volume = {10},
year = {2020}
}

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TY  - JOUR
AB  - 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.
AU  - Craig,Z
AU  - Swain,J
AU  - Batman,E
AU  - Wadsley,J
AU  - Reed,N
AU  - Faluyi,O
AU  - Cave,J
AU  - Sharma,R
AU  - Chau,I
AU  - Wall,L
AU  - Lamarca,A
AU  - Hubner,R
AU  - Mansoor,W
AU  - Sarker,D
AU  - Meyer,T
AU  - Cairns,DA
AU  - Howard,H
AU  - Valle,JW
AU  - McNamara,MG
DO  - 10.1136/bmjopen-2019-034527
EP  - 034527
PY  - 2020///
SN  - 2044-6055
SP  - 034527
TI  - 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).
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2019-034527
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32029495
UR  - https://bmjopen.bmj.com/content/10/2/e034527
UR  - http://hdl.handle.net/10044/1/76761
VL  - 10
ER  -

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