Assessment of QoL and Outcomes With SBRT for RCC

Study Overview
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Brief Summary
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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
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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).

Official Title
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Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) - AQuOS-RCC

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: ECOG ≥3 Prior abdominal radiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br>RCC patients | Radiation: SBRT<br>* 35-40 Gy delivered in 5 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Quality of Life | To evaluate quality of life scores | Up to 5 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-Effectiveness | To assess health utility scores and correlate with QoL | Up to 5 years after completion of treatment | 
| Oncologic Outcomes | To evaluate local control | Up to 5 years after completion of treatment | 
| Oncologic Outcomes | To evaluate progression-free survival | Up to 5 years after completion of treatment | 
| Oncologic Outcomes | To evaluate overall survival | Up to 5 years after completion of treatment | 
| Treatment-Related Toxicity | To report number of participants with treatment-related toxicities as assessed by CTCAE v4.0 | Up to 5 years after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCC, Stereotactic Body Radiotherapy, SBRT, Stereotactic Ablative Radiotherapy, SABR