Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT
Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study
Sunnybrook Health Sciences Centre
70 participants
Feb 8, 2022
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- 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
- ECOG 0-2
- Written informed consent
- Participants must be able to understand the English-language or with the aid of a translator
Exclusion Criteria6
- Primary Lesion >20cm
- Evidence of distant metastatic disease
- Previous abdominal RT in vicinity of kidney preventing definitive SBRT
- History of major radiosensitivity syndrome
- Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer)
- Currently pregnant or lactating
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Interventions
SBRT 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.
Locations(1)
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NCT05023265