Evidence map›Paper›PMID 30116024›Full record

Trial reportBritish journal of cancer2018

A prospective phase II study of pre-operative chemotherapy then short-course radiotherapy for high risk rectal cancer: COPERNICUS.

Simon Gollins, Nicholas West, David Sebag-Montefiore, Shabbir Susnerwala, Stephen Falk, Nick Brown, Mark Saunders, Philip Quirke, Ruby Ray, Philip Parsons and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 7% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  7. Article
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  9. Neoadjuvant Therapy for Rectal Cancer.Surgical oncology clinics of North America · 2022
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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

14 authors at 9 institutions in 1 country.

Simon GollinsNorth Wales Cancer Treatment Centre, Bodelwyddan, Denbighshire, LL18 5UJ, UK. simon.gollins@wales.nhs.uk.
Nicholas WestPathology and Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, LS9 7TF, UK.
David Sebag-MontefioreLeeds Institute of Cancer and Pathology, University of Leeds and Leeds Cancer Centre, Leeds, LS9 7TF, UK.
Shabbir SusnerwalaRoyal Preston Hospital, Fulwood, Preston, PR2 9HT, UK.
Stephen FalkBristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, BS2 8ED, UK.
Nick BrownCalderdale Royal Hospital, Salterhebble, Halifax, HX3 0PW, UK.
Mark SaundersThe Christie NHS Foundation Trust, Withington, Manchester, M20 4BX, UK.
Philip QuirkePathology and Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, LS9 7TF, UK.
Ruby RayCentre for Trials Research, Cardiff University, Room 409, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Philip ParsonsNCRI RTTQA, Velindre Cancer Centre, Velindre NHS Trust, Velindre Road, Cardiff, CF14 2TL, UK.
Gareth GriffithsSouthampton Clinical Trials Unit, Faculty of Medicine, Univeristy of Southampton, Tremona Road, Southampton, SO16 6YD, UK.
Tim MaughanCRUK/MRC Oxford Institute for Radiation Oncology, University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Oxford, OX3 7DQ, UK.
Richard AdamsCentre for Trials Research, Cardiff University, Room 409, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Chris HurtCentre for Trials Research, Cardiff University, Room 409, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.ORCID http://orcid.org/0000-0003-1206-8355
Cardiff University · GBUniversity of Leeds · GBCalderdale Royal Hospital · GBNorth Wales Hospital · GBRoyal Preston Hospital · GBThe Christie NHS Foundation Trust · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Oxford · GBVelindre NHS Trust · GB

Funding

Cancer Research UK 25350Cancer Research UK 25352
6 · The paper itself

Abstract

backgroundNeoadjuvant chemotherapy (NAC) allows earlier treatment of rectal cancer micro-metastases but is not standard of care. There are currently no biomarkers predicting long-term progression-free survival (PFS) benefit from NAC. PATIENTS AND

methodsIn this single arm phase II trial, patients with non-metastatic magnetic resonance imaging (MRI)-defined operable rectal adenocarcinoma at high risk of post-operative metastatic recurrence, received 8 weeks of oxaliplatin/fluorouracil NAC then short-course preoperative radiotherapy (SCPRT) before immediate surgery. Sixteen weeks of post-operative adjuvant chemotherapy (AC) was planned. A pelvic MRI was performed at week 9 immediately post-NAC, before SCPRT. The primary end point was feasibility assessed by completion of protocol treatment up to and including surgery. Secondary endpoints included compliance, toxicity, downstaging efficacy, and PFS.

resultsIn total 60 patients were recruited May 2012-June 2014. In total 57 patients completed protocol treatment, meeting the primary endpoint. Compliance with NAC was much better than AC: Comparing NAC vs. AC, the median percentage dose intensity for fluoropyrimidine was 100% vs. 63% and for oxaliplatin 100% vs. 45%. Treatment-related toxicity was acceptable with no treatment-related deaths. Post-NAC MRI showed 44 tumours (73%) were T-downstaged and 22 (37%) had excellent MRI tumour regression grade (mrTRG 1-2). Median follow-up was 27 months with 2-year PFS of 86.2% (10 events). On exploratory analysis, post-NAC mrTRG predicted PFS with no event among those with excellent regression.

conclusionThe regimen was well tolerated with effective downstaging and encouraging PFS. mrTRG response to NAC may be a new prognostic factor for long-term PFS, but needs validation in larger studies.

Indexed as

AdultAgedChemotherapy, AdjuvantCombined Modality TherapyDrug Administration ScheduleFeasibility StudiesFemaleFluorouracilHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm StagingOxaliplatinPatient ComplianceProspective StudiesFluorouracilOxaliplatin

Identifiers

PMID30116024
PMCPMC6173784
OpenAlexW2885732278

What OpenQuestion holds

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LicenceCC BY
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.