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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with lack of progressive disease for the index site at 1 year
CT will be used for evaluation of the status of the local disease at the index site.
Rebecca K.S. Wong, MB ChB
University Health Network - Princess Margaret Cancer Center
Canada: Ethics Review Committee