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

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ClinicalTrials.gov Identifier: NCT01493206
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia

Brief Summary:
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Condition or disease Intervention/treatment Phase
Malignant Rectal Neoplasm Recurrent Tumor Radiation: intraoperative radiotherapy Phase 2

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  (Clinical Trial)
Actual Enrollment : 32 participants
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
Study Start Date : July 2004
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: intraoperative radiotherapy Radiation: intraoperative radiotherapy
intraoperative radiotherapy




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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT01493206     History of Changes
Other Study ID Numbers: PMCC04/16
First Posted: December 15, 2011    Key Record Dates
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