Evidence map›Paper›PMID 32029495›Full record

ArticleBMJ open2020

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).

Zoe Craig, Jayne Swain, Emma Batman, Jonathan Wadsley, Nicholas Reed, Olusola Faluyi, Judith Cave, Rohini Sharma, Ian Chau, Lucy Wall and 9 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 NCT03837977 (A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan), 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
2.0field-weighted citation impact, top 13% 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.

NCT03837977 phase2completednot on this map

A Multi-centre, 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 Extra-pulmonary Neuroendocrine Carcinoma (NEC))

TypeinterventionalSponsorThe Christie NHS Foundation TrustRan2018 to 2024Enrolled58ConditionsOncology, Neuroendocrine CarcinomaArmsLiposomal Irinotecan, Fluorouracil, Folinic Acid, Docetaxel
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Chemotherapy in NEN: still has a role?Reviews in endocrine & metabolic disorders · 2021
    Review
  8. Article
  9. Article
  10. Review
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

19 authors at 12 institutions in 1 country.

Zoe CraigClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.ORCID 0000-0001-9930-6648
Jayne SwainClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.
Emma BatmanClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.
Jonathan WadsleyDepartment of Oncology, Weston Park Hospital, Sheffield, Sheffield, UK.
Nicholas ReedBeatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK.
Olusola FaluyiClatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, UK.
Judith CaveDepartment of Oncology, University Hospital Southampton NHS Foundation Trust, Southampton, Southampton, UK.
Rohini SharmaDepartment of Surgery and Cancer, Imperial College London, London, London, UK.
Ian ChauGastrointestinal and Lymphoma Unit, Royal Marsden Hospital NHS Trust, London, London, UK.
Lucy WallDepartment of Oncology, Western General Hospital, Edinburgh, UK.
Angela LamarcaDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
R HubnerDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Wasat MansoorDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Debashis SarkerComprehensive Cancer Centre, King's College Hospital, London, UK.
Tim MeyerDepartment of Oncology, University College London Cancer Institute, London, UK.
David A CairnsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.
Helen HowardClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.
Juan W ValleDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Mairéad G McNamaraDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK Mairead.McNamara@christie.nhs.uk.
University of Leeds · GBUniversity of Manchester · GBBeatson West of Scotland Cancer Centre · GBClatterbridge Cancer Centre NHS Foundation Trust · GBImperial College London · GBKing's College Hospital · GBLondon Cancer · GBRoyal Marsden Hospital · GBThe Christie NHS Foundation Trust · GBUniversity Hospital Southampton NHS Foundation Trust · GBWestern General Hospital · GBWeston Park Cancer Centre · GB

Funding

Cancer Research UK 25447Cancer Research UK C7852/A25447
6 · The paper itself

Abstract

introductionPoorly 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.

Indexed as

Carcinoma, NeuroendocrineAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase II as TopicDocetaxelFluorouracilHumansIrinotecanLeucovorinMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicDocetaxelFluorouracilIrinotecanLeucovorindocetaxelliposomal irinotecanneuroendocrine carcinomarandomisedsingle-stage

Identifiers

PMID32029495
PMCPMC7045240
OpenAlexW3004899162

What OpenQuestion holds

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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.