Status:
COMPLETED
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Malignant Rectal Neoplasm
Recurrent Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 greate...
Eligibility Criteria
Inclusion
- 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
- unresectable pelvic disease
- distant metastasis
- significant co-morbidities
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01493206
Start Date
July 1 2004
End Date
August 1 2011
Last Update
May 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006