NCT03747133

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress84%
Nov 2018Nov 2027

First Submitted

Initial submission to the registry

November 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

9 years

First QC Date

November 1, 2018

Last Update Submit

February 18, 2025

Conditions

Renal Tumor

Keywords

Stereotactic Body Radiation TherapySABRRadiation TherapyRenal Cell CarcinomaRCC

Outcome Measures

Primary Outcomes (1)

  • To evaluate the radiation induced renal impairments in patients receiving SABR.

    The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.

    2 years

Secondary Outcomes (4)

  • Chronic Kidney Disease Stage Progression

    2 years

  • 2-year Local recurrence rate

    2 years

  • Patient Reported Outcomes

    2 years

  • Incidence of acute and late toxicities

    2 years

Study Arms (1)

Stereotactic Ablative Radiotherapy

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Radiotherapy

Interventions

Stereotactic Ablative RadiotherapyRADIATION

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

Stereotactic Ablative Radiotherapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • ≥5 active metastases
  • Sysstemic therapy (except endocrine therapy) wthin 6 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

NOT YET RECRUITING

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

  • Glicksman RM, Winter J, McPartlin A, Santiago AT, Wang K, Bernstein J, Dang J, Tsui G, Chung P, Mesci A, Gutierrez Valencia E, Raman S, Berlin A, Catton C, Bayley A, Warde P, Krishna S, Finelli A, Hamilton RJ, Pace KT, Kitchlu A, Helou J. Stereotactic Body Radiation Therapy for Renal Tumors: A Prospective Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2025 Nov 23:S0360-3016(25)06480-6. doi: 10.1016/j.ijrobp.2025.11.005. Online ahead of print.

    PMID: 41290048DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Study Officials

  • Andrew McPartlin, MD

    The Princess Margaret Cancer Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew McPartlin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 20, 2018

Study Start

November 1, 2018

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

CA(2)