A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Phase 2
Completed
- Conditions
- Malignant Rectal NeoplasmRecurrent Tumor
- Interventions
- Radiation: intraoperative radiotherapy
- Registration Number
- NCT01493206
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intraoperative radiotherapy intraoperative radiotherapy -
- Primary Outcome Measures
Name Time Method clinical outcomes 3-year locoregional control, progression-free and overall survival rates.
- Secondary Outcome Measures
Name Time Method toxicities 3-6 monthly up to 30 months Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Trial Locations
- Locations (1)
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia