Clinical trial NCT03108703: Assessment of QoL and Outcomes With SBRT for 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: RCC
Stereotactic Body Radiotherapy
SBRT
Stereotactic Ablative Radiotherapy
SABR
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Center
First posted: 2017-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Quality of Life
timeFrame: Up to 5 years after treatment
Secondary outcomes:
measure: Cost-Effectiveness
timeFrame: Up to 5 years after completion of treatment
measure: Oncologic Outcomes
timeFrame: Up to 5 years after completion of treatment
measure: Oncologic Outcomes
timeFrame: Up to 5 years after completion of treatment
measure: Oncologic Outcomes
timeFrame: Up to 5 years after completion of treatment
measure: Treatment-Related Toxicity
timeFrame: Up to 5 years after completion of treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre, Sunnybrook Health Science Centre
state: Ontario
Study officials:
References: