Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Neoplasm

Intervention / Treatment
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* Radiation: Photon Radiosurgery System IORT
* Radiation: Photon Radiosurgery System IORT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operable rectal cancer Exclusion Criteria: Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 Gray IORT<br> | Radiation: Photon Radiosurgery System IORT<br> <br> |
| Experimental: 15 Gray IORT<br> | Radiation: Photon Radiosurgery System IORT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complication rate |  | 30 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 5 year | 
| local control |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal neoplasm C04.588.274.476.411.307.790, Intraoperative Radiotherapy