Recruiting

SABR

Sponsor:

University Health Network, Toronto

Code:

NCT03747133

Conditions

Renal Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Ablative Radiotherapy

Study Details

Brief summary:

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Conditions

Renal Tumor

Study ID

NCT03747133

Start date

Nov 1, 2018

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
  • Histological or radiological diagnosis of renal tumor
  • Inoperable: High risk for surgery or declined surgery
  • ECOG performance status of 0-3

Exclusion Criteria:

  • ≥5 active metastases
  • Systemic therapy (except endocrine therapy) within 60 days prior to SABR
  • Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
  • Patients with end stage renal failure > 4(KDOQI guidelines)
  • Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic Ablative Radiotherapy

Adult patients with Kidney mass (either primary or metastasis) amenable to SABR

Interventions

Stereotactic Ablative Radiotherapy

Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.

Primary outcome measure

  • To evaluate the radiation induced renal impairments in patients receiving SABR. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Rachel Glicksman, MD

416-946-4501rachel.glicksman@uhn.ca

Locations

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

416-946-4501andrew.mcpartlin@rmp.uhn.ca

Principal Investigator:

Andrew McPartlin, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Stereotactic Body Radiation Therapy
  • SABR
  • Radiation Therapy
  • Renal Cell Carcinoma
  • RCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-04.