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

Recurrent Tumor Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Rectal Neoplasm
• Rectal Neoplasms
• Recurrent Tumor

• NCT number: NCT01493206
• Study type: Interventional
• Source: Peter MacCallum Cancer Centre, Australia
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Completion date: August 2011