Evidence map›Paper›PMID 26861457›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2016

Clinical Trial of Oral Nelfinavir before and during Radiation Therapy for Advanced Rectal Cancer.

Esme J Hill, Corran Roberts, Jamie M Franklin, Monica Enescu, Nicholas West, Thomas P MacGregor, Kwun-Ye Chu, Lucy Boyle, Claire Blesing, Lai-Mun Wang and 11 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Drivers of Radioresistance in Prostate Cancer.Journal of clinical medicine · 2022
    Review
  8. Article
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  10. Review
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  15. Phase I trial of concurrent stereotactic body radiotherapy and nelfinavir for locally advanced borderline or unresectable pancreatic adenocarcinoma.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2019
    Article
  16. Review
  17. Article
  18. Functional Parameters Derived from Magnetic Resonance Imaging Reflect Vascular Morphology in Preclinical Tumors and in Human Liver Metastases.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Article
  19. Article
  20. Article
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

21 authors at 7 institutions in 1 country.

Esme J HillOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Corran RobertsCentre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
Jamie M FranklinOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Monica EnescuInstitute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.
Nicholas WestSection of Pathology and Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, St James's University Hospital, Leeds, United Kingdom.
Thomas P MacGregorOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Kwun-Ye ChuOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Lucy BoyleOncology Clinical Trials Office (OCTO), Department of Oncology, University of Oxford, Oxford, United Kingdom.
Claire BlesingOxford University Hospitals NHS Trust, Churchill Hospital, Oxford, United Kingdom.
Lai-Mun WangOxford University Hospitals NHS Trust, Churchill Hospital, Oxford, United Kingdom.
Somnath MukherjeeOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Ewan M AndersonOxford University Hospitals NHS Trust, Churchill Hospital, Oxford, United Kingdom.
Gina BrownRadiology Department, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.
Susan DuttonCentre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
Sharon B LoveCentre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
Julia A SchnabelInstitute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.
Phil QuirkeSection of Pathology and Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, St James's University Hospital, Leeds, United Kingdom.
Ruth MuschelOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
William G McKennaOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Michael PartridgeOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom.
Ricky A SharmaOxford Cancer Imaging Centre and NIHR Oxford Biomedical Research Centre, Department of Oncology, University of Oxford, Oxford, United Kingdom. ricky.sharma@oncology.ox.ac.uk.
Oxford BioMedica (United Kingdom) · GBChurchill Hospital · GBNuffield Orthopaedic Centre · GBScience Oxford · GBSt James's University Hospital · GBRoyal Marsden NHS Foundation Trust · GBUniversity of Oxford · GB

Funding

Cancer Research UK 16049Cancer Research UK 16466Cancer Research UK 16895Cancer Research UK 20407Cancer Research UK 8971Cancer Research UK A16466Department of Health OXFBRC-2012-1
6 · The paper itself

Abstract

purposeNelfinavir, a PI3K pathway inhibitor, is a radiosensitizer that increases tumor blood flow in preclinical models. We conducted an early-phase study to demonstrate the safety of nelfinavir combined with hypofractionated radiotherapy (RT) and to develop biomarkers of tumor perfusion and radiosensitization for this combinatorial approach. EXPERIMENTAL

designTen patients with T3-4 N0-2 M1 rectal cancer received 7 days of oral nelfinavir (1,250 mg b.i.d.) and a further 7 days of nelfinavir during pelvic RT (25 Gy/5 fractions/7 days). Perfusion CT (p-CT) and DCE-MRI scans were performed pretreatment, after 7 days of nelfinavir and prior to the last fraction of RT. Biopsies taken pretreatment and 7 days after the last fraction of RT were analyzed for tumor cell density (TCD).

resultsThere were 3 drug-related grade 3 adverse events: diarrhea, rash, and lymphopenia. On DCE-MRI, there was a mean 42% increase in medianKtrans, and a corresponding median 30% increase in mean blood flow on p-CT during RT in combination with nelfinavir. Median TCD decreased from 24.3% at baseline to 9.2% in biopsies taken 7 days after RT (P= 0.01). Overall, 5 of 9 evaluable patients exhibited good tumor regression on MRI assessed by tumor regression grade (mrTRG).

conclusionsThis is the first study to evaluate nelfinavir in combination with RT without concurrent chemotherapy. It has shown that nelfinavir-RT is well tolerated and is associated with increased blood flow to rectal tumors. The efficacy of nelfinavir-RT versus RT alone merits clinical evaluation, including measurement of tumor blood flow.

Indexed as

Administration, OralAgedAged, 80 and overBiomarkersCombined Modality TherapyFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedNelfinavirNeoplasm MetastasisNeoplasm StagingRadiation-Sensitizing AgentsRectal NeoplasmsTomography, X-Ray ComputedBiomarkersNelfinavirRadiation-Sensitizing Agents

Identifiers

PMID26861457
PMCPMC4835023
OpenAlexW2283317566

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.