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Stereotactic radiotherapy versus HDR brachytherapy (Ir-192, reloading procedure) for T1 (=7 cm) inoperable, non-metastatic renal tumours 2017-2023

Stereotactic radiotherapy versus HDR brachytherapy (Ir-192, reloading procedure) for T1 (=7 cm) inoperable, non-metastatic renal tumours 2017-2023

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038822
Enrollment
100
Registered
2025-12-22
Start date
2025-09-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C64

Interventions

Group 1: Patient group 1 underwent CT-guided high-dose-rate brachytherapy with iridium-192 using an afterloading technique. The applied single dose ranged from 15 to 25 Gy. Clinical and imaging routin

Sponsors

Universitätsklinik für Strahlentherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026