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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014