Back to resultsA Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Primary Purpose
Malignant Rectal Neoplasm, Recurrent Tumor
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
intraoperative radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Rectal Neoplasm focused on measuring intraoperative radiotherapy
Eligibility 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
Sites / Locations
- Peter MacCallum Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intraoperative radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
clinical outcomes
locoregional control, progression-free and overall survival rates.
Secondary Outcome Measures
toxicities
Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Full Information
NCT ID
NCT01493206
First Posted
December 13, 2011
Last Updated
December 14, 2011
Sponsor
Peter MacCallum Cancer Centre, Australia
1. Study Identification
Unique Protocol Identification Number
NCT01493206
Brief Title
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Official Title
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Rectal Neoplasm, Recurrent Tumor
Keywords
intraoperative radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intraoperative radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiotherapy
Intervention Description
intraoperative radiotherapy
Primary Outcome Measure Information:
Title
clinical outcomes
Description
locoregional control, progression-free and overall survival rates.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
toxicities
Description
Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Time Frame
3-6 monthly up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Ngan
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
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