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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:
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier:
NCT01493206
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • clinical outcomes [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    locoregional control, progression-free and overall survival rates.


Secondary Outcome Measures:
  • toxicities [ Time Frame: 3-6 monthly up to 30 months ] [ Designated as safety issue: Yes ]
    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
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT01493206     History of Changes
Other Study ID Numbers: PMCC04/16
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013