Back to resultsIntraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System
Primary Purpose
Rectal Neoplasm
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Photon Radiosurgery System IORT
Photon Radiosurgery System IORT
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasm focused on measuring Rectal neoplasm C04.588.274.476.411.307.790, Intraoperative Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Operable rectal cancer
Exclusion Criteria:
- Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
Sites / Locations
- University of Dundee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
12 Gray IORT
15 Gray IORT
Arm Description
Outcomes
Primary Outcome Measures
surgical complication rate
Secondary Outcome Measures
survival
local control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00910494
Brief Title
Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System
Official Title
Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
No longer practical to deliver treatment
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasm
Keywords
Rectal neoplasm C04.588.274.476.411.307.790, Intraoperative Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 Gray IORT
Arm Type
Experimental
Arm Title
15 Gray IORT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Photon Radiosurgery System IORT
Intervention Type
Radiation
Intervention Name(s)
Photon Radiosurgery System IORT
Primary Outcome Measure Information:
Title
surgical complication rate
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
survival
Time Frame
5 year
Title
local control
Time Frame
5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Operable rectal cancer
Exclusion Criteria:
Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alastair Munro, MBChB
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dundee
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System
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