Recruiting

SBRT

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05023265

Conditions

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic body radiotherapy

Study Details

Brief summary:

This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).

Conditions

Renal Cell Carcinoma

Study ID

NCT05023265

Start date

Feb 8, 2022

Status verified date

Apr, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT for Medically Inoperable RCC

35-45 Gy in five fractions (7-9 Gy/day)

Interventions

Stereotactic body radiotherapy

SBRT is a non-invasive treatment approach that delivers precise and highly conformal radiotherapy to the tumour with steep dose gradients that minimize exposure to the surrounding normal tissues.

Primary outcome measure

  • Local Control at 2 years [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Chris Zehr

416-480-6100chris.zehr@sunnybrook.ca

Kerri Durrant

416-480-6100keri.durrant@sunnybrook.ca

Locations

Sunnybrook Health Sciences

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-28.