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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Rectal Neoplasm

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Trial Information

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


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.


Inclusion Criteria:



- Operable rectal cancer

Exclusion Criteria:

- Locally advanced disease requiring long course pre-operative chemoradiation,
metastatic disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

surgical complication rate

Outcome Time Frame:

30 days post treatment

Safety Issue:

Yes

Principal Investigator

Alastair Munro, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Dundee

Authority:

United Kingdom: National Health Service

Study ID:

EB/JK/LET/LN1277

NCT ID:

NCT00910494

Start Date:

January 2010

Completion Date:

January 2017

Related Keywords:

  • Rectal Neoplasm
  • Rectal neoplasm C04.588.274.476.411.307.790
  • Intraoperative Radiotherapy
  • Neoplasms
  • Rectal Neoplasms

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