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ACTIVE NOT RECRUITING
NCT05877352
NA

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Sponsor: University Hospital Southampton NHS Foundation Trust

View on ClinicalTrials.gov

Summary

Single centre double-blinded three-arm randomised controlled trial of extended margin surgery + IOERT at standard dose (10 Gy) versus extended margin surgery + IOERT at higher dose (15 Gy) versus extended margin surgery alone in a 1:1:1 ratio in patients with Locally Advanced Rectal Cancer (LARC) or Locally Recurrent Rectal Cancer (LRRC).

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2022-05-18

Completion Date

2025-07-25

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

RADIATION

Intraoperative Electron Radiotherapy (IOERT)

IOERT can be defined as the direct application of high-energy electron beam irradiation to a tumour bed during an operative procedure. This approach permits precise delivery of a single large fraction of radiation directly and specifically to high recurrence risk anatomical target areas, which the treating clinicians (surgeon and attending clinical oncologist) predict will be a close or involved margin, while simultaneously displacing and shielding dose-limiting radiosensitive structures such as the small bowel or ureter or any anastomoses, if not involved by tumour.

PROCEDURE

Extended Margin Surgery

Surgery intended to remove both a tumour and any metastases

Locations (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom