Evidence map›Paper›PMID 27117177›Full record

Trial reportRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2016

ARCII: A phase II trial of the HIV protease inhibitor Nelfinavir in combination with chemoradiation for locally advanced inoperable pancreatic cancer.

James M Wilson, Emmanouil Fokas, Susan J Dutton, Neel Patel, Maria A Hawkins, Cynthia Eccles, Kwun-Ye Chu, Lisa Durrant, Aswin G Abraham, Mike Partridge and 6 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
3.5field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 51 citations in OpenAlex.

  1. Correlation ofClinical oncology (Royal College of Radiologists (Great Britain)) · 2017
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  16. Lipid metabolism and cancer.The Journal of experimental medicine · 2021
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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

16 authors at 4 institutions in 2 countries.

James M WilsonDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Emmanouil FokasDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Susan J DuttonCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.
Neel PatelDepartment of Radiology, Oxford University Hospitals NHS Foundation Trust, UK.
Maria A HawkinsDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Cynthia EcclesDepartment of Radiotherapy, Oxford University Hospitals NHS Foundation Trust, UK.
Kwun-Ye ChuDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK; Department of Radiotherapy, Oxford University Hospitals NHS Foundation Trust, UK.
Lisa DurrantDepartment of Radiotherapy, Oxford University Hospitals NHS Foundation Trust, UK.
Aswin G AbrahamDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Mike PartridgeDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Martha WoodwardEarly Phase Research Hub, Department of Oncology, Oxford Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust, UK.
Eric O'NeillDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Tim MaughanDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
W Gillies McKennaDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK.
Somnath MukherjeeDepartment of Oncology, CRUK/MRC Institute for Radiation Oncology, University of Oxford, UK. Electronic address: somnath.mukherjee@oncology.ox.ac.uk.
Thomas B BrunnerDepartment of Radiation Oncology, University of Freiburg, Germany; German Cancer Consortium (DKTK), Heidelberg, Partner Site Freiburg, Germany.
University of Oxford · GBOxford University Hospitals NHS Trust · GBNuffield Orthopaedic Centre · GBUniversity of Freiburg · DE

Funding

Cancer Research UK 16049Cancer Research UK 16466Cancer Research UK 19277Medical Research Council MC_PC_12001/2Medical Research Council MC_PC_12004
6 · The paper itself

Abstract

background and purposeNelfinavir can enhance intrinsic radiosensitivity, reduce hypoxia and improve vascularity. We conducted a phase II trial combining nelfinavir with chemoradiotherapy (CRT) for locally advanced inoperable pancreatic cancer (LAPC). MATERIALS AND

methodsRadiotherapy (50.4Gy/28 fractions; boost to 59.4Gy/33 fractions) was administered with weekly gemcitabine and cisplatin. Nelfinavir started 3-10days before and was continued during CRT. The primary end-point was 1-year overall survival (OS). Secondary end-points included histological downstaging, radiological response, 1-year progression free survival (PFS), overall survival (OS) and treatment toxicity. An imaging sub-study (n=6) evaluated hypoxia ((18)F-Fluoromisonidazole-PET) and perfusion (perfusion CT) during induction nelfinavir.

resultsThe study closed after recruiting 23 patients, due to non-availability of Nelfinavir in Europe. The 1-year OS was 73.4% (90% CI: 54.5-85.5%) and median OS was 17.4months (90% CI: 12.8-18.8). The 1-year PFS was 21.8% (90% CI: 8.9-38.3%) and median PFS was 5.5months (90% CI: 4.1-8.3). All patients experienced Grade 3/4 toxicity, but many were asymptomatic laboratory abnormalities. Four of 6 patients on the imaging sub-study demonstrated reduced hypoxia and increased perfusion post-nelfinavir.

conclusionsCRT combined with nelfinavir showed acceptable toxicity and promising survival in pancreatic cancer.

Indexed as

ChemoradiotherapyCombined Modality TherapyDisease-Free SurvivalFemaleHIV Protease InhibitorsHumansMaleMiddle AgedNelfinavirPancreatic NeoplasmsHIV Protease InhibitorsNelfinavirHypoxiaImagingNelfinavirPancreatic cancerRadiosensitisationTrial

Identifiers

PMID27117177
PMCPMC4917892
OpenAlexW2339415504

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.