5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases

Official Title

A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases


This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule. The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.

Trial Description

Primary Outcome:

  • Proportion of patients with lack of progressive disease for the index site at 1 year
Secondary Outcome:
  • Number of index lesion(s) with lack of progressive disease at 1 year.
  • Acute toxicity within 90 days of first fraction of radiation therapy
  • Time to local progression for the index site(s)
  • Time to distant disease progression (beyond known sites of oligometastases at time of study entry)
  • Late toxicity occuring beyond 90 days related to SBRT.
  • Describe symptom profile
  • Examine radiation therapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities
Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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