ELECTRA

Title

A double-blinded feasibility study of intraoperative electron beam radiotherapy in patients with locally advanced or locally recurrent rectal cancer.

Description

ELECTRA is a feasibility trial to determine whether it is acceptable and feasible to recruit, randomise and deliver Intraoperative Electron Radiotherapy (IOERT) in a randomised controlled trial setting. Patients with locally advanced rectal cancer or locally recurrent rectal cancer involving the pelvic sidewall or posterior bony pelvis will be randomised to receive either extended margin surgery along, extended margin surgery with IOERT at standard dose (10 Gy), or extended margin surgery with IOERT at higher dose (15 Gy). Patients will be randomised to the three treatment arms in a 1:1:1 ratio. Patients will be followed up for a minimum of 12 months and up to 24 months following their surgery.

Objectives

Primary:

• To determine acceptability and feasibility of recruiting, randomising and delivering IOERT in a randomised controlled trial (RCT) setting as preparatory work for a future late phase RCT.

Secondary:

• To evaluate whether proposed data collection methods which would be used to assess effectiveness and cost-effectiveness endpoints are feasible and appropriate for this population.
• To obtain pilot oncological, quality of life (QoL), and health economics (HE) data on patients treated with or without IOERT as a modality to inform future RCT studies.

Trial Design

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

Trial Status

Closed to recruitment / in follow-up

Population

Patients with locally advanced rectal cancer (LARC) or locally recurrent rectal cancer (LRRC) involving the pelvic sidewall or posterior bony pelvis, and predicted narrow or close surgical margins at the commencement of their treatment pathway and prior to neoadjuvant therapy.

This trial is funded by IntraOp and endorsed by Cancer Research UK (award reference no. CRCPJT\100036), with support from the PLANETS charity.