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Protocol for a multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR).

Dean A Harris1, Kymberley Thorne2, Hayley Hutchings2

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This study assesses omitting preoperative radiotherapy for rectal cancer patients undergoing abdominoperineal excision of the rectum (APER). It aims to determine if surgery alone is feasible, potentially reducing toxicity for select patients.

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Area of Science:

  • Oncology
  • Surgical Oncology
  • Radiation Oncology

Background:

  • Rectal cancer treatment involves surgery, with preoperative radiotherapy (RT) improving local recurrence rates.
  • Advances in MRI and surgical techniques necessitate reassessing the role of RT.
  • High-quality surgery is crucial for minimizing local recurrence in rectal cancer.

Purpose of the Study:

  • To explore the feasibility of a definitive trial investigating the omission of preoperative RT in specific rectal cancer cases.
  • To evaluate the potential for a more selective approach to RT based on predicted resection margins.
  • To assess the safety and efficacy of abdominoperineal excision of the rectum (APER) surgery alone.

Main Methods:

  • A feasibility trial randomizing patients with resectable low rectal cancer to standard care (neoadjuvant RT±chemotherapy and APER) or APER surgery alone.
  • Inclusion criteria: cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI.
  • Standard RT schedule: 45 Gy over 5 weeks, with surgery after 8-12 weeks; recruitment for 24 months with 12-month follow-up.

Main Results:

  • The primary objective is to test the feasibility of patient recruitment, consent, and retention for a definitive trial.
  • Secondary objectives include quantifying eligible patients and assessing feasibility of outcome measures like locoregional recurrence, margin status, and toxicity.
  • Close monitoring of MRI staging, RT delivery, and surgical specimen quality is planned.

Conclusions:

  • This feasibility study will inform the design of a definitive trial on omitting preoperative radiotherapy for selected rectal cancer patients.
  • Findings will guide a more selective use of radiotherapy, potentially reducing treatment toxicity.
  • The study aims to establish whether APER surgery alone is a viable option for certain low rectal cancer cases.