AQuOS-RCC: Assessment of QoL and Outcomes With SBRT for RCC

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03108703

Collaborator

Juravinski Cancer Center (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Radiation: SBRT	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SBRT RCC patients	Radiation: SBRT 35-40 Gy delivered in 5 fractions

Arm

Intervention/Treatment

Experimental: SBRT

RCC patients

Radiation: SBRT

35-40 Gy delivered in 5 fractions

Outcome Measures

Primary Outcome Measures

Patient Quality of Life [Up to 5 years after treatment]
To evaluate quality of life scores

Secondary Outcome Measures

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 local control
Oncologic Outcomes [Up to 5 years after completion of treatment]
To evaluate progression-free survival
Oncologic Outcomes [Up to 5 years after completion of treatment]
To evaluate overall survival
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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