A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
18 Years
N/A
Both
Malignant Rectal Neoplasm, Recurrent Tumor
Trial Information
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
clinical outcomes
Outcome Description:
locoregional control, progression-free and overall survival rates.
Outcome Time Frame:
3-year
Safety Issue:
No
Principal Investigator
Sam Ngan
Investigator Role:
Principal Investigator
Investigator Affiliation:
Peter MacCallum Cancer Centre, Australia
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
PMCC04/16
NCT ID:
NCT01493206
Start Date:
July 2004
Completion Date:
August 2011
Related Keywords:
- Malignant Rectal Neoplasm
- Recurrent Tumor
- intraoperative radiotherapy
- Neoplasms
- Rectal Neoplasms
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