Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

Not Applicable

Terminated

• Conditions: Rectal Neoplasm
• Interventions: Radiation: Photon Radiosurgery System IORT

• Registration Number: NCT00910494
• Lead Sponsor: University of Dundee

Brief Summary

The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

Detailed Description

Rectal cancer is usually managed by a combination of surgery and x-ray treatments (radiotherapy). The standard way of delivering radiotherapy is with external 'beams' directed at the tumour site. However, although in rectal cancer these treatments are effective, patients are often troubled by late side effects. An alternative option is to deliver the x-rays at the same time as surgery. This is known as intraoperative radiotherapy, or IORT, and a number of techniques have already been tried. There is a new IORT technology known as the Photon Radiosurgery System (PRS) which we are using to treat breast and brain cancers. Our experience to date has informed us that IORT with this x-ray source is safe and effective. We would like to use the technology to treat rectal cancer and believe that it may improve disease outcomes without the side effects associated with standard radiotherapy. We would also like to study the biological processes that follow radiation. It is not understood why some people are more sensitive to x-ray treatments than others. If we knew the reasons for this then we might be able to individualise treatments.

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Study Start: 2010-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-22
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Operable rectal cancer

Exclusion Criteria

• Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 Gray IORT	Photon Radiosurgery System IORT	-
12 Gray IORT	Photon Radiosurgery System IORT	-

Primary Outcome Measures

Name	Time	Method
surgical complication rate	30 days post treatment

Secondary Outcome Measures

Name	Time	Method
survival	5 year
local control	5 year

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, Tayside, United Kingdom