Assessment of QoL and Outcomes With SBRT for RCC

Not Applicable

Active, not recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT03108703
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

There is an evolving body of literature that shows high rates of tumour control and minimal associated toxicities with SBRT to treat RCC. However, the majority of published evidence is retrospective in nature, and there is a scarcity of data on the impact on quality of life and cost-effectiveness of kidney SBRT.

The principal aims of this multicentre study are to prospectively assess QoL and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of primary renal cell carcinoma.

The study population will include 30 consecutive patients treated with kidney SBRT on a conventional linear accelerator (35-40 Gy in 5 fractions) at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto (OCC) and the Juravinski Cancer Center, Hamilton Health Sciences Centre, McMaster University (JCC).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2017-03-19
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

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Exclusion Criteria

• ECOG ≥3
• Prior abdominal radiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	RCC patients

Primary Outcome Measures

Name	Time	Method
Patient Quality of Life	Up to 5 years after treatment	To evaluate quality of life scores

Secondary Outcome Measures

Name	Time	Method
Treatment-Related Toxicity	Up to 5 years after completion of treatment	To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0
Cost-Effectiveness	Up to 5 years after completion of treatment	To assess health utility scores and correlate with QoL
Oncologic Outcomes	Up to 5 years after completion of treatment	To evaluate overall survival

Trial Locations

Locations (2)

Odette Cancer Centre, Sunnybrook Health Science Centre; 🇨🇦 Toronto, Ontario, Canada

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada