A Phase 2 interventional study of Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance in Solid Tumors With Oligometastatic Spread, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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.
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.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
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.
Time frame: 10 years
Number of index lesion(s) with lack of progressive disease at 1 year.
The Modified Response Evaluation Criteria for solid Tumors (RECIST) will be used. By measuring the longest diameter (LD) of the lesions, response of individual lesions and overall response will be documented.
Time frame: 10 years
Acute toxicity within 90 days of first fraction of radiotherapy
Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0
Time frame: 10 years
Time to local progression for the index site(s)
Time frame: 10 years
Time to distant disease progression (beyond known sites of oligometastases at time of study entry)
Time frame: 10 years
Late toxicity occuring beyond 90 days related to SBRT.
Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.
Time frame: 10 year
Describe symptom profile
Time frame: 10 Years
Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities
Time frame: 10 years
Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval
Time frame: 10 years
Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year
Time frame: 10 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto