This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).
Patients ≥18 years old
Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months)
Primary lesion >3 cm, or recurrent lesion following local ablative therapy
Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting
Primary Lesion >20cm
Evidence of distant metastatic disease
Previous abdominal RT in vicinity of kidney preventing definitive SBRT
History of major radiosensitivity syndrome
Single group
Stereotactic body radiotherapy
RadiationSBRT is a non-invasive treatment approach that delivers precise and highly conformal radiotherapy to the tumour with steep dose gradients that minimize exposure to the surrounding normal tissues.
Local Control at 2 years
Local control at 2 years defined as the absence of progression of disease of the treated primary kidney cancer using Responsive Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Severity of late treatment-related toxicity
Maximum CTCAE grade recorded
Incidence of late treatment-related toxicity
Assessed using NCI CTCAE v4.0
Quality of life score (e.g., EPIC-26 or other tool)
Change from baseline
Late Toxicity
Assessed using NCI CTCAE v4.0
Dosimetric parameters
Dosimetric parameters (i.e. amount of radiation) to organs at risk (stomach, duodenum, small bowel, large bowel, liver, and normal kidneys) will be collected prospectively for all patients for any correlation between the amount of radiation to specific organs and the presence of toxicities (e.g. stomach upset, nausea/vomiting, diarrhea).
Anatomic Parameters
Size, volume and localisation of the kidney tumour relative to organs at risk (stomach, duodenum, liver, normal kidney) will be collected prospectively for all patients.
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Sunnybrook Health Sciences Centre
Lead sponsor
Juravinski Cancer Center
Collaborator
Health Sciences North
Collaborator
Grand River Regional Cancer Centre
Collaborator
British Columbia Cancer Agency
Collaborator
London Health Sciences Centre
Collaborator
Durham Regional Cancer Centre
Collaborator
