NCT05023265

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2022Oct 2026

First Submitted

Initial submission to the registry

August 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

August 5, 2021

Last Update Submit

April 27, 2026

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Local Control at 2 years

    Local control at 2 years defined as the absence of progression of disease of the treated primary kidney cancer using Responsive Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    2 years

Secondary Outcomes (4)

  • Severity of late treatment-related toxicity

    6-60 months

  • Incidence of late treatment-related toxicity

    6-60 months post-SBRT

  • Quality of life score (e.g., EPIC-26 or other tool)

    Months 3, 6, 9, 12, 18, 24, 36, 48, and 60 post-SBRT

  • Late Toxicity

    Week 4-6 post-SBRT

Other Outcomes (2)

  • Dosimetric parameters

    Baseline, Day 3, week 4-6 post-SBRT, and months: 3,6,9,12,18,24,36,48 and 60

  • Anatomic Parameters

    Baseline and months: 3,6,12,18,24,36,48 and 60 post SBRT

Study Arms (1)

SBRT for Medically Inoperable RCC

EXPERIMENTAL

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

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapyRADIATION

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.

SBRT for Medically Inoperable RCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • William Chu, MD, FRCPC

    Sunnybrook Health Sciences Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Zehr

CONTACT

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

Kerri Durrant

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients diagnosed with Inoperable Renal Cell Carcinoma
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Radiation Oncology, University of Toronto

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 26, 2021

Study Start

February 8, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)