Evidence map›Paper›PMID 30717707›Full record

ArticleBMC cancer2019

Study protocol: a multi-centre randomised study of induction chemotherapy followed by capecitabine ± nelfinavir with high- or standard-dose radiotherapy for locally advanced pancreatic cancer (SCALOP-2).

Victoria Y Strauss, Rachel Shaw, Pradeep S Virdee, Christopher N Hurt, Elizabeth Ward, Bethan Tranter, Neel Patel, John Bridgewater, Philip Parsons, Ganesh Radhakrishna and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02024009 (A Multi-centre Randomised Study of Induction Chemotherapy Followed by Capecitabine), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT02024009 phase1 / phase2completednot on this map

A Multi-centre Randomised Study of Induction Chemotherapy Followed by Capecitabine (+/-Nelfinavir) With High or Standard Dose Radiotherapy for Locally Advanced Non-metastatic Pancreatic Cancer

TypeinterventionalSponsorUniversity of OxfordRan2016 to 2021Enrolled159ConditionsPancreatic Neoplasms (Locally Advanced Non-metastatic)Armsnab-paclitaxel, 60Gy in 30#, 50.4Gy in 28#, Nelfinavir, Capecitabine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Recurrence patterns of pancreatic cancer treated with adjuvant intensity modulated radiotherapy.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2022
    Article
  6. Review
  7. Review
  8. 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

16 authors.

Victoria Y StraussCentre for Statistics in Medicine, University of Oxford, Oxford, UK.
Rachel ShawOncology Clinical Trials Office, University of Oxford, Oxford, UK.
Pradeep S VirdeeCentre for Statistics in Medicine, University of Oxford, Oxford, UK.
Christopher N HurtCentre for Trials Research, Cardiff University, Cardiff, UK.
Elizabeth WardClinical Trials and Evaluation Unit, Bristol Royal Infirmary, Bristol, UK.
Bethan TranterPharmacy Department, Velindre Cancer Centre, Velindre NHS University Trust, Cardiff, UK.
Neel PatelDepartment of Radiology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.
John BridgewaterDepartment of Oncology, University College London Hospitals, London, UK.
Philip ParsonsCardiff NCRI RTTQA group, Department of Medical Physics, Velindre Cancer Centre, Cardiff, UK.
Ganesh RadhakrishnaOncology Department, The Christie NHS Foundation Trust, Wilmslow Road, Manchester, UK.
Eric O'NeillDepartment of Oncology, University of Oxford, CRUK MRC Oxford Institute for Radiation Oncology, Oxford, UK.
David Sebag-MontefioreUniversity of Leeds, Leeds Cancer Centre, St James's University Hospital, Leeds, UK.
Maria HawkinsDepartment of Oncology, University of Oxford, CRUK MRC Oxford Institute for Radiation Oncology, Oxford, UK.
Pippa G CorrieCambridge Cancer Centre, Addenbrooke's Hospital, Cambridge, UK.
Timothy MaughanDepartment of Oncology, University of Oxford, CRUK MRC Oxford Institute for Radiation Oncology, Oxford, UK.
Somnath MukherjeeDepartment of Oncology, University of Oxford, CRUK MRC Oxford Institute for Radiation Oncology, Oxford, UK. somnath.mukherjee@oncology.ox.ac.uk.ORCID http://orcid.org/0000-0002-7202-0698

Funding

Cancer Research UK 15954Cancer Research UK 16895Cancer Research UK 17139Cancer Research UK 19277Cancer Research UK 25350Cancer Research UK CRUK/07/040Medical Research Council MC_PC_12001/2Medical Research Council MC_UU_00001/2
6 · The paper itself

Abstract

backgroundInduction chemotherapy followed by chemoradiation is a treatment option for patients with locally advanced pancreatic cancer (LAPC). However, overall survival is comparable to chemotherapy alone and local progression occurs in nearly half of all patients, suggesting chemoradiation strategies should be optimised. SCALOP-2 is a randomised phase II trial testing the role of radiotherapy dose escalation and/or the addition of the radiosensitiser nelfinavir, following induction chemotherapy of gemcitabine and nab-paclitaxel (GEMABX). A safety run-in phase (stage 1) established the nelfinavir dose to administer with chemoradiation in the randomised phase (stage 2).

methodsPatients with locally advanced, inoperable, non-metastatic pancreatic adenocarcinoma receive three cycles of induction GEMABX chemotherapy prior to radiological assessment. Those with stable/responding disease are eligible for further trial treatment. In Stage 1, participants received one further cycle of GEMABX followed by capecitabine-chemoradiation with escalating doses of nelfinavir in a rolling-six design. Stage 2 aims to register 262 and randomise 170 patients with responding/stable disease to one of five arms: capecitabine with high- (arms C + D) or standard-dose (arms A + B) radiotherapy with (arms A + C) or without (arms B + D) nelfinavir, or three more cycles of GEMABX (arm E). Participants allocated to the chemoradiation arms receive another cycle of GEMABX before chemoradiation begins. Co-primary outcomes are 12-month overall survival (radiotherapy dose-escalation question) and progression-free survival (nelfinavir question). Secondary outcomes include toxicity, quality of life, disease response rate, resection rate, treatment compliance, and CA19-9 response. SCALOP-2 incorporates a detailed radiotherapy quality assurance programme. DISCUSSION: SCALOP-2 aims to optimise chemoradiation in LAPC and incorporates a modern induction regimen.

trial registrationEudract No: 2013-004968-56; ClinicalTrials.gov : NCT02024009.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyInduction ChemotherapyNeoplasms, Second PrimaryPancreatic NeoplasmsAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCapecitabineClinical Trials, Phase II as TopicCombined Modality TherapyFemaleHumansAntineoplastic AgentsCapecitabineNelfinavirChemoradiationGemcitabine and nab-paclitaxel (GEMABX)Locally advanced pancreatic cancer (LAPC)Nelfinavir

Identifiers

PMID30717707
PMCPMC6360784

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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.