Renal Cell Carcinoma
Conditions
Keywords
RCC, Stereotactic Body Radiotherapy, SBRT, Stereotactic Ablative Radiotherapy, SABR
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).
Interventions
RADIATIONSBRT
35-40 Gy delivered in 5 fractions
Sponsors
Juravinski Cancer Center
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life | Up to 5 years after treatment | To evaluate quality of life scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Canada
Outcome results
None listed