Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- surgical complication rate [ Time Frame: 30 days post treatment ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- Operable rectal cancer
Exclusion Criteria:
- Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
Contacts and Locations| Contact: Alastair Munro, MBChB | 00441382496491 | a.j.munro@dundee.ac.uk |
| Contact: Ian Sanders, MBChB | 00441382496404 | i.sanders@dundee.ac.uk |
| 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 | |
| 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 May 16, 2013