CCC publication: 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)

Citation: BMJ Open. 2020, 10(2), e034527
Author: Zoe Craig, Jayne Swain, Emma Batman, Jonathan Wadsley, Nicholas Reed, Olusola Faluyi, Judith Cave, Rohini Sharma, Ian Chau, Lucy Wall, Angela Lamarca, R Hubner, Wasat Mansoor, Debashis Sarker, Tim Meyer, David A Cairns, Helen Howard, Juan W Valle, Mairéad G McNamara
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.
Keywords:  docetaxel; liposomal irinotecan; neuroendocrine carcinoma; randomised; single-stage.

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