Evidence map›Paper›PMID 29288190›Full record

Trial reportBMJ open2017

Can we

Anouk J M Rombouts, Issam Al-Najami, Natalie L Abbott, Ane Appelt, Gunnar Baatrup, Simon Bach, Aneel Bhangu, Karen-Lise Garm Spindler, Richard Gray, Kelly Handley and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02945566 (STAR-TREC), which is not on this map. Cited by 48 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 2 pooled it
4.2field-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.

NCT02945566 phase2 / phase3active not recruitingnot on this map

STAR-TREC: Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?

TypeinterventionalSponsorUniversity of BirminghamRan2017 to 2028Enrolled380ConditionsAdenocarcinoma of the RectumArmsStandard TME surgery, Long course concurrent chemoradiation with capecitabine and radiotherapy, Short course radiotherapy
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  5. Article
  6. Review
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  11. Transanal Minimally Invasive Surgery for Rectal Cancer.South Asian journal of cancer · 2024
    Review
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  13. Review
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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

26 authors at 13 institutions in 3 countries.

Anouk J M RomboutsDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
Issam Al-NajamiDepartment of Surgery, Odense University Hospital, Odense, Denmark.
Natalie L AbbottRadiotheraphy Trials Quality Assurance Group, Velindre Cancer Centre, Cardiff, UK.
Ane AppeltLeeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
Gunnar BaatrupDepartment of Surgery, Odense University Hospital, Odense, Denmark.
Simon BachDepartment of Surgery, University Hospitals Birmingham, Birmingham, UK.
Aneel BhanguDepartment of Surgery, University Hospitals Birmingham, Birmingham, UK.
Karen-Lise Garm SpindlerDepartment of Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.
Richard GrayClinical Trial Services Unit, University of Oxford, Oxford, UK.
Kelly HandleyInstitue of Applied Health Research, University of Birmingham Clinical Trials Unit, Birmingham, UK.
Manjinder KaurBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Ellen KerkhofDepartment of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
Camilla Jensenius KronborgDepartment of Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.
Laura MagillBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Corrie A M MarijnenDepartment of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
Iris D NagtegaalDepartment of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Lars NyvangDepartment of Medical Physics, Aarhus University Hospital, Aarhus, Denmark.
Femke P PetersDepartment of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
Per PfeifferDepartment of Oncology, Odense University Hospital, Odense, Denmark.
Cornelis PuntDepartment of Medical Oncology, Academic Medical Center, Amsterdam, The Netherlands.
Philip QuirkeDepartment of Pathology, School of Medicine, University of Leeds, Leeds, UK.
David Sebag-MontefioreDepartment of Clinical Oncology, Leeds Radiotherapy Research Group, University of Leeds, Leeds, UK.
Mark TeoDepartment of Clinical Oncology, Leeds Radiotherapy Research Group, University of Leeds, Leeds, UK.
Nick WestDepartment of Pathology, School of Medicine, University of Leeds, Leeds, UK.
Johannes H W de WiltDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
for STAR-TREC Collaborative Group
Leiden University Medical Center · NLOdense University Hospital · DKRadboud University Nijmegen · NLUniversity of Leeds · GBAarhus University Hospital · DKCancer Research UK Clinical Trials Unit · GBNIHR Surgical Reconstruction and Microbiology Research Centre · GBSt James's University Hospital · GBAarhus University · DKAcademic Medical Center · NLUniversity of Birmingham · GBUniversity of Oxford · GBVelindre Cancer Centre · GB

Funding

Cancer Research UK 19393Cancer Research UK C41557/A19393
6 · The paper itself

Abstract

introductionTotal mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery. METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2. ETHICS AND DISSEMINATION: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.

Indexed as

Organ Sparing TreatmentsAdenocarcinomaChemoradiotherapyDigestive System Surgical ProceduresEuropeFeasibility StudiesHumansMicrosurgeryRectal NeoplasmsRectumRegression AnalysisResearch DesignTreatment OutcomeWatchful Waitingchemoradiationradiotherapyrectal cancerTEMwatchful waiting

Identifiers

PMID29288190
PMCPMC5770914
OpenAlexW2785124974

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.