Assessment of QoL and Outcomes With SBRT for RCC (AQuOS-RCC)

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Renal Cell Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03108703

052-2015

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SBRT

Experimental group

Description:

RCC patients

Treatment:

Radiation: SBRT