C64
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - ECOG Performance Status = 3 • Newly diagnosed, primary, unifocal renal cell carcinoma, stage cT1N0M0 o cT1a (= 4 cm) o cT1b (> 4 cm to = 7 cm) • Inoperable, for example, due to significant comorbidities, contraindication to anesthesia, or refusal of surgery • Imaging or histological confirmation of diagnosis; all histological subtypes (e.g., clear cell, papillary, chromophobe) are included • Eligible for solitary kidneys, provided no nephrectomy has been performed due to a second tumor. • Availability of the following pre- and post-therapeutic examinations: o MRI of the kidney o Staging CT scan of the thorax and abdomen o eGFR, serum creatinine o Renal scintigraphy, if necessary • Radiotherapy administered between 2017 and 2023 • Follow-up period of at least two years
Exclusion criteria
Exclusion criteria: Patients with a history of previous nephrectomy due to a secondary tumor • History of systemic therapy affecting kidney function due to concurrent tumor disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to evaluate whether stereotactic ablative radiotherapy (SBRT) is not inferior to iridium-192-based high-dose-rate brachytherapy (HDR-BT) in patients with T1N0M0 renal cell carcinoma with regard to the following clinical endpoints: Primary endpoint: Local tumour control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| A dosimetric comparison of the radiation plans (HDR-BT vs. SBRT) will be used to investigate the following: Secondary endpoints: • Distal tumour control rate • Treatment-related side effects, particularly with regard to kidney function • Coverage of the clinical target volume (CTV) and the quality of dose distribution | — |
Countries
Germany