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Clinical Trials/NCT00910494
NCT00910494
Terminated
Not Applicable

Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial

University of Dundee1 site in 1 country9 target enrollmentJanuary 2010
ConditionsRectal Neoplasm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Neoplasm
Sponsor
University of Dundee
Enrollment
9
Locations
1
Primary Endpoint
surgical complication rate
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
March 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ian Sanders

Specialist Registrar

University of Dundee

Eligibility Criteria

Inclusion Criteria

  • Operable rectal cancer

Exclusion Criteria

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

Outcomes

Primary Outcomes

surgical complication rate

Time Frame: 30 days post treatment

Secondary Outcomes

  • survival(5 year)
  • local control(5 year)

Study Sites (1)

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