A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

Peter MacCallum Cancer Centre, Australia32 enrolled

Overview

The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Rectal Neoplasm Recurrent Tumor

Interventions

intraoperative radiotherapyRADIATION

intraoperative radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

clinical outcomes

locoregional control, progression-free and overall survival rates.

Time frame: 3-year

Secondary Outcomes

toxicities

Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria

Time frame: 3-6 monthly up to 30 months

Data from ClinicalTrials.gov

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