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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493206
First Posted: December 15, 2011
Last Update Posted: December 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia
  Purpose
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Condition Intervention Phase
Malignant Rectal Neoplasm Recurrent Tumor Radiation: intraoperative radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

Further study details as provided by Peter MacCallum Cancer Centre, Australia:

Primary Outcome Measures:
  • clinical outcomes [ Time Frame: 3-year ]
    locoregional control, progression-free and overall survival rates.


Secondary Outcome Measures:
  • toxicities [ Time Frame: 3-6 monthly up to 30 months ]
    Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria


Enrollment: 32
Study Start Date: July 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intraoperative radiotherapy Radiation: intraoperative radiotherapy
intraoperative radiotherapy

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493206


Locations
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
Principal Investigator: Sam Ngan Peter MacCallum Cancer Centre, Australia
  More Information

Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT01493206     History of Changes
Other Study ID Numbers: PMCC04/16
First Submitted: December 13, 2011
First Posted: December 15, 2011
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Peter MacCallum Cancer Centre, Australia:
intraoperative radiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases