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Completed

NCT Number: NCT01493206

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

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

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Key information

Conditions

Malignant Rectal Neoplasm Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Recurrence Recurrent Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraoperative radiotherapy

Radiation

intraoperative radiotherapy

Primary outcomes

  1. clinical outcomes

    Time frame: 3-year

    locoregional control, progression-free and overall survival rates.

Secondary outcomes

  1. toxicities

    Time frame: 3-6 monthly up to 30 months

    Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2011
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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