Assessment of QoL and Outcomes With SBRT for RCC

Renal Cell Carcinoma Clinical Trial

— AQuOS-RCC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108703
• Other study ID #: 052-2015
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Radiation:
• SBRT
35-40 Gy delivered in 5 fractions

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Odette Cancer Centre, Sunnybrook Health Science Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Juravinski Cancer Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Quality of Life	To evaluate quality of life scores	Up to 5 years after treatment
Secondary	Cost-Effectiveness	To assess health utility scores and correlate with QoL	Up to 5 years after completion of treatment
Secondary	Oncologic Outcomes	To evaluate local control	Up to 5 years after completion of treatment
Secondary	Oncologic Outcomes	To evaluate progression-free survival	Up to 5 years after completion of treatment
Secondary	Oncologic Outcomes	To evaluate overall survival	Up to 5 years after completion of treatment
Secondary	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