Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by University of Dundee
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00910494
First received: May 28, 2009
Last updated: June 24, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • surgical complication rate [ Time Frame: 30 days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • local control [ Time Frame: 5 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 28, 2009
Last Updated: June 24, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014