Quality of life and outcomes after SBRT for primary kidney cancer
Official title: Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study
Run by Sunnybrook Health Sciences Centre · NCT05023265 · Data updated 2026-11-12
This trial will test whether stereotactic body radiotherapy (SBRT) helps people with primary kidney cancer who cannot or will not have surgery and how it affects their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | February 8, 2022 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT05023265 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with newly diagnosed or recurrent primary renal cell carcinoma who are medically inoperable or decline surgery, have a primary lesion generally larger than 3 cm (and not exceeding the protocol size limit), no distant metastases, and ECOG 0–2 are the ideal candidates.
✕Probably not a fit
Patients with evidence of distant metastatic disease, primary lesions larger than the protocol size limit, prior abdominal radiation that prevents SBRT, major radiosensitivity syndromes, recent other invasive cancers, or who are pregnant or lactating are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single‑arm phase II trial using stereotactic body radiotherapy (SBRT) to treat medically inoperable or surgery‑refusing patients with primary renal cell carcinoma. Participants receive highly focused, high‑dose radiation targeted to the kidney tumor while sparing surrounding tissues. The study will prospectively record tumor control, treatment‑related side effects, and patients' quality of life over time. Eligibility focuses on adults with localized tumors (generally >3 cm and ≤20 cm) without distant metastases and with ECOG performance status 0–2.
Why it matters
Potential benefit: If successful, SBRT could offer a noninvasive treatment that controls the kidney tumor while preserving quality of life for patients who cannot or choose not to have surgery.
How similar studies have gone: Previous single‑arm series and small prospective cohorts worldwide have reported promising local control and tolerable toxicity with SBRT for renal cell carcinoma, but large randomized comparisons are still lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥18 years old * Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months) * Primary lesion \>3 cm, or recurrent lesion following local ablative therapy * Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting * ECOG 0-2 * Written informed consent * Participants must be able to understand the English-language or with the aid of a translator Exclusion Criteria: * Primary Lesion \>20cm * Evidence of distant metastatic disease * Previous abdominal RT in vicinity of kidney preventing definitive SBRT * History of major radiosensitivity syndrome * Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer) * Currently pregnant or lactating
Where it's running
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Sunnybrook Health Sciences
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: William Chu, MD, FRCPC — Sunnybrook Health Sciences Centre
- Study coordinator: Chris Zehr
- Email: chris.zehr@sunnybrook.ca
- Phone: 416-480-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.