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Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Dundee.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910494
First Posted: June 1, 2009
Last Update Posted: June 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Dundee
  Purpose
The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

Condition Intervention Phase
Rectal Neoplasm Radiation: Photon Radiosurgery System IORT Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • surgical complication rate [ Time Frame: 30 days post treatment ]

Secondary Outcome Measures:
  • survival [ Time Frame: 5 year ]
  • local control [ Time Frame: 5 year ]

Estimated Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 Gray IORT Radiation: Photon Radiosurgery System IORT
Experimental: 15 Gray IORT Radiation: Photon Radiosurgery System IORT

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operable rectal cancer

Exclusion Criteria:

  • Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910494


Contacts
Contact: Alastair Munro, MBChB 00441382496491 a.j.munro@dundee.ac.uk
Contact: Ian Sanders, MBChB 00441382496404 i.sanders@dundee.ac.uk

Locations
United Kingdom
University of Dundee Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Contact: Alastair Munro, MBChB    00441382496491    a.j.munro@dundee.ac.uk   
Contact: Ian Sanders, MBChB    00441382496404    i.sanders@dundee.ac.uk   
Principal Investigator: Alastair Munro, MBChB         
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Alastair Munro, MBChB University of Dundee
  More Information

Responsible Party: James Houston (Director of Research and Innovation Services), University of Dundee
ClinicalTrials.gov Identifier: NCT00910494     History of Changes
Other Study ID Numbers: EB/JK/LET/LN1277
First Submitted: May 28, 2009
First Posted: June 1, 2009
Last Update Posted: June 25, 2010
Last Verified: June 2010

Keywords provided by University of Dundee:
Rectal neoplasm C04.588.274.476.411.307.790
Intraoperative Radiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases