A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

December 14, 2011 updated by: Peter MacCallum Cancer Centre, Australia
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • locally advanced or recurrent rectal cancer
  • suitable for radical surgery but at high risk of positive resection margins,
  • no evidence of metastasis,
  • age greater than 18 years,
  • histologically confirmed adenocarcinoma,
  • ECOG performance status <2.
  • Informed consent

Exclusion Criteria:

  • unresectable pelvic disease
  • distant metastasis
  • significant co-morbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intraoperative radiotherapy
Radiation: intraoperative radiotherapy
intraoperative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcomes
Time Frame: 3-year
locoregional control, progression-free and overall survival rates.
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicities
Time Frame: 3-6 monthly up to 30 months
Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
3-6 monthly up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Investigators

  • Principal Investigator: Sam Ngan, Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMCC04/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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