NCT03108703

Brief Summary

Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely delivers high doses of radiation to tumours. It has been investigated as definitive treatment for an increasing variety of primary tumours including lung, liver, prostate, and now renal cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of RCC.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

10.5 years

First QC Date

March 19, 2017

Last Update Submit

December 5, 2023

Conditions

Keywords

RCCStereotactic Body RadiotherapySBRTStereotactic Ablative RadiotherapySABR

Outcome Measures

Primary Outcomes (1)

  • Patient Quality of Life

    To evaluate quality of life scores

    Up to 5 years after treatment

Secondary Outcomes (5)

  • Cost-Effectiveness

    Up to 5 years after completion of treatment

  • Oncologic Outcomes

    Up to 5 years after completion of treatment

  • Oncologic Outcomes

    Up to 5 years after completion of treatment

  • Oncologic Outcomes

    Up to 5 years after completion of treatment

  • Treatment-Related Toxicity

    Up to 5 years after completion of treatment

Study Arms (1)

SBRT

EXPERIMENTAL

RCC patients

Radiation: SBRT

Interventions

SBRTRADIATION

35-40 Gy delivered in 5 fractions

SBRT

Eligibility Criteria

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

You may qualify if:

  • Patients ≥18 years old
  • Medically inoperable or patient who refuses surgery
  • Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance
  • Lesion ≥2.5cm or recurrent lesion following local ablative therapy
  • Written informed consent
  • Participants must be able to understand the English-language or with the aid of a translator

You may not qualify if:

  • ECOG ≥3
  • Prior abdominal radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Odette Cancer Centre, Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

March 19, 2017

First Posted

April 11, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations