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Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial

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Abstract

Background

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery.

Methods

Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity.

Results

Thirty-one patients were enrolled: 15 were randomized to 6 and 16–12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups.

Conclusions

The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

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Acknowledgments

Patient recruitment and data collection were performed by clinical teams and research nurses at the participating research sites. We would like to thank the following clinicians, research nurses and administrators whose hard work is much appreciated: Louise Saunders, Katrina Kirby, Ann Lyons (North Bristol); Clare Adams, Mark Coleman, Laura Evenden, Hilary Rowley, Ellie Shepherd (Plymouth); Erica Beaumont, Joanne Taylor, Paul Mackey, Ian Eyre-Brooke (Taunton); Hema Arumugam, Darren Beech, Richard Ellis, Melanie Feldman, Philip Harvey, Kirsty Maclean, Nick Morley (Truro); Karen Bobruk, Rebecca Houlihan, Katrina Hurley, Catherine Philpott, Jonathan Randall, Mike Thomas (University Hospitals Bristol); Nitya Chandratreya, Deborah Coles, Harvey Dymond, Krishna Kandaswamy, Hugh Lloyd-Jones, Vivienne Pixton (Weston Super-Mare); additionally Brendan Moran and Siobhan Creanor for participating on the Steering Committee; Steve Gore, Nicky Marks, Joanna Allison, Andrea Bradshaw, Katie Spurdle, Hannah Thurlow and Tressy Pitt-Kerby for their help, support and assistance in undertaking this study. The TCD calculations were assisted by Emma Tinkler-Hundal, Dan Bottomley, Mike Hale, Dave Turner and Martin Waterhouse. Pathology and Tumour Biology at the University of Leeds is supported by Yorkshire Cancer Research, the Pathological Society of Great Britain and Ireland, the Academy of Medical Sciences, the Experimental Cancer Medicines Centre and the Medical Research Council.

The names of the "STARRCAT Investigators" Group are as follows: - Mr. Ponnandai Arumugam, Department of Surgery, Royal Cornwall Hospital, Truro, UK. - Mr. Anthony Dixon, Department of Surgery, North Bristol NHS Trust, Bristol, UK. - Mr. Tom Edwards, Department of Surgery, Musgrove Park Hospital, Taunton, UK. - Mr. Robert Longman, Department of Surgery, University Hospitals Bristol, Bristol, UK. - Dr. David Sherriff, Department of Oncology, Derriford Hospital, Plymouth, UK. - Mr. Reuben West, Department of Surgery, Weston General Hospital, Weston-Super-Mare, UK. - Mr. Andrew Allison, Department of Surgery, Yeovil District Hospital, Yeovil, UK. - Mr. Jonathan Ockrim, Department of Surgery, Yeovil District Hospital, Yeovil, UK.

Funding

This work was supported by the UK National Institute for Health Research, through the Research for Patient Benefit Program (Grant PB-PG-1010-23326). The funding body did not have any role in the planning of the study, recruitment, data collection or analysis.

Author information

Authors and Affiliations

  1. Department of Surgery, Yeovil District Hospital, Higher Kingston, Yeovil, UK

    J. D. Foster & N. K. Francis

  2. Department of Surgery and Cancer, St Mary’s Hospital, Imperial College, London, UK

    J. D. Foster & G. B. Hanna

  3. Southwest Research Design Service, Taunton and Somerset NHS Trust, Taunton, UK

    P. Ewings

  4. University Hospitals Bristol, Upper Maudlin Street, Bristol, UK

    S. Falk & H. Roach

  5. Department of Pathology, Yeovil District Hospital, Higher Kingston, Yeovil, UK

    E. J. Cooper

  6. Leeds Institute of Cancer and Pathology, School of Medicine, St James’s University Hospital, University of Leeds, Leeds, UK

    N. P. West

  7. Department of Research and Development, St Mary’s Hospital, Imperial College, London, UK

    B. A. Williams-Yesson

  8. Faculty of Science, University of Bath, Wessex House 3.22, Bath, BA2 7AY, UK

    N. K. Francis

Authors
  1. J. D. Foster
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  2. P. Ewings
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  3. S. Falk
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  4. E. J. Cooper
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  5. H. Roach
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  6. N. P. West
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  7. B. A. Williams-Yesson
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  8. G. B. Hanna
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  9. N. K. Francis
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Consortia

STARRCAT Investigators

  • Ponnandai Arumugam
  • , Anthony Dixon
  • , Tom Edwards
  • , Robert Longman
  • , David Sherriff
  • , Reuben West
  • , Andrew Allison
  •  & Jonathan Ockrim

Corresponding author

Correspondence to N. K. Francis.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study was approved by the South West England (Exeter) Research Ethics Committee (reference 12/SW/0112) and locally at recruiting centres. Patient representatives were consulted during trial design and protocol development and were active members of the study management group and steering committee.

Informed consent

Written informed consent was obtained prior to randomization and commencing CRT.

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Foster, J.D., Ewings, P., Falk, S. et al. Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial. Tech Coloproctol 20, 683–693 (2016). https://doi.org/10.1007/s10151-016-1514-7

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  • DOI: https://doi.org/10.1007/s10151-016-1514-7

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