Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

Rectal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00910494
• Other study ID #: EB/JK/LET/LN1277
• Status: Terminated
• Phase: N/A
• First received: May 28, 2009
• Last updated: April 22, 2018
• Start date: January 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Operable rectal cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Rectal Neoplasm
• Rectal Neoplasms

Intervention

Radiation:
• Photon Radiosurgery System IORT

• Photon Radiosurgery System IORT

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical complication rate		30 days post treatment
Secondary	survival		5 year
Secondary	local control		5 year