Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study

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  • Anouk J M Rombouts, Department of Surgery, Radboud University Medical Centre, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
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  • Issam Al-Najami, Department of Vascular Surgery, Odense University Hospital, Odense, Denmark
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  • Natalie L Abbott, Radiotheraphy Trials Quality Assurance Group, Velindre Cancer Centre, Cardiff, UK.
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  • Ane Appelt, Leeds Cancer Centre, St. James' University Hospital, Leeds, UK.
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  • Gunnar Baatrup, Department of Vascular Surgery, Odense University Hospital, Odense, Denmark
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  • Simon Bach, Colorectal Surgery Department, Queen Elizabeth Hospital University Hospitals Birmingham NHS Foundation Trust Birmingham UK.
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  • Aneel Bhangu, Colorectal Surgery Department, Queen Elizabeth Hospital University Hospitals Birmingham NHS Foundation Trust Birmingham UK.
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  • Karen-Lise Garm Spindler
  • Richard Gray, Clinical Trial Services Unit, University of Oxford, Oxford, UK.
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  • Kelly Handley, Institue of Applied Health Research, University of Birmingham Clinical Trials Unit, Birmingham, UK.
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  • Manjinder Kaur, Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
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  • Ellen Kerkhof, Department of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
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  • Camilla Jensenius Kronborg
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  • Laura Magill, Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
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  • Corrie A M Marijnen, Department of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
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  • Iris D Nagtegaal, Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands.
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  • Lars Nyvang
  • Femke P Peters, Department of Radiotherapy, Leiden University Medical Center, Leiden, The Netherlands.
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  • Per Pfeiffer, 7 Department of Oncology, Odense University Hospital, Odense, Denmark.
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  • Cornelis Punt, Department of Radiation Oncology Academic Medical Center, University of Amsterdam, The Netherlands.
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  • Philip Quirke, Department of Pathology, School of Medicine, University of Leeds, Leeds, UK.
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  • David Sebag-Montefiore, Department of Clinical Oncology, Leeds Radiotherapy Research Group, University of Leeds, Leeds, UK.
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  • Mark Teo, Department of Clinical Oncology, Leeds Cancer Centre, St James University Hospital, Leeds, UK.
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  • Nick West, Department of Pathology, School of Medicine, University of Leeds, Leeds, UK.
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  • Johannes H W de Wilt, Department of Surgery, Radboud University Medical Centre, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
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  • for STAR-TREC Collaborative Group

INTRODUCTION: Total 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.

OriginalsprogEngelsk
TidsskriftBMJ Open
Vol/bind7
Nummer12
Sider (fra-til)e019474
ISSN2044-6055
DOI
StatusUdgivet - 28 dec. 2017

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