TY - JOUR
T1 - NET-02 trial protocol
T2 - 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)
AU - Craig, Zoe
AU - Swain, Jayne
AU - Batman, Emma
AU - Wadsley, Jonathan
AU - Reed, Nicholas
AU - Faluyi, Olusola
AU - Cave, Judith
AU - Rohini, Sharma
AU - Chau, Ian
AU - Wall, Lucy
AU - Lamarca, Angela
AU - Hubner, Richard
AU - Mansoor, Wasat
AU - Sarker, Debashis
AU - Meyer, Tim
AU - Cairns, David A.
AU - Howard, Helen
AU - Valle, Juan
AU - Mcnamara, Mairead
N1 - Funding Information:
Funding This research is investigator initiated and funded by an unrestricted educational grant from Servier (grant reference number 016-34263). This work was also supported by Core Clinical Trials Unit Infrastructure from Cancer Research UK (C7852/A25447). SPONSOR: The Christie NHS Foundation Trust, Wilmslow Road, Manchester, M20 4BX, UK. Sponsor reference: CFTSp116.
Funding Information:
The NET-02 trial opened to recruitment on 16 November 2018. At the time of submission, 12 centres out of 16 are open to recruitment, and 17 participants have been randomised into the trial. The trial is currently adhering to V.3.0 of the protocol (approved 20 September 2018), with all sites opening to this version of the protocol. The trial is sponsored by The Christie NHS Foundation Trust, coordinated by Leeds CTRU and funded by Servier (unrestricted grant).
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
PY - 2020/2/5
Y1 - 2020/2/5
N2 - 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
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
KW - Neuroendocrine carcinoma
KW - randomised
KW - single-stage
KW - liposomal irinotecan
KW - docetaxel
KW - neuroendocrine carcinoma
KW - Humans
KW - Irinotecan/therapeutic use
KW - Randomized Controlled Trials as Topic
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Docetaxel/therapeutic use
KW - Fluorouracil/therapeutic use
KW - Multicenter Studies as Topic
KW - Carcinoma, Neuroendocrine/drug therapy
KW - Quality of Life
KW - Clinical Trials, Phase II as Topic
KW - Leucovorin/therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=85079084289&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/6f29ece9-cc63-3686-a0e4-3343b118dc3b/
U2 - 10.1136/bmjopen-2019-034527
DO - 10.1136/bmjopen-2019-034527
M3 - Article
C2 - 32029495
SN - 2044-6055
VL - 10
SP - e034527
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e034527
ER -
