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Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

NCT ID: NCT00910494

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-03-31

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).

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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.

Conditions

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Rectal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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12 Gray IORT

Group Type EXPERIMENTAL

Photon Radiosurgery System IORT

Intervention Type RADIATION

15 Gray IORT

Group Type EXPERIMENTAL

Photon Radiosurgery System IORT

Intervention Type RADIATION

Interventions

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Photon Radiosurgery System IORT

Intervention Type RADIATION

Photon Radiosurgery System IORT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Operable rectal cancer

Exclusion Criteria

* Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Ian Sanders

Specialist Registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alastair Munro, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

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University of Dundee

Dundee, Tayside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EB/JK/LET/LN1277

Identifier Type: -

Identifier Source: org_study_id

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