Research Experiment Details
Title: Head-to-head comparison of robotic-assisted partial nephrectomy (RAPN) and stereotactic ablative radiotherapy (SABR)
Consortium members:
Leader: Medical University of Gdańsk
Principal Investigator: dr n. med. Bartłomiej Tomasik
Consortium partners: Nicolaus Copernicus University in Toruń
Consortium Investigator: prof. dr hab. Tomasz Drewa, FEBU
Sub-Investigator: dr hab. Jan Adamowicz, prof. UMK
Research Experiment Description
The research experiment aims to compare two treatment approaches for localized renal cell carcinoma (RCC): robotic-assisted partial nephrectomy (RAPN) and stereotactic ablative body radiotherapy (SABR). While surgery remains the standard treatment for localized RCC, advances in modern radiotherapy have created the opportunity to offer an effective, non-invasive alternative for selected patients.
The study will assess the impact of both treatment methods on kidney function preservation and compare their oncological effectiveness, safety, and effects on patients’ quality of life. The project will provide the first direct comparative evidence regarding these two treatment strategies in patients with operable RCC.
The results of the research may contribute to expanding available treatment options and support physicians and patients in making individualized treatment decisions.
Recruitment status: Coming soon
Study phase: Phase III
Simplified inclusion criteria:
- Age ≥18 years
- Diagnosis of renal cell carcinoma (RCC) confirmed by biopsy, with no more than one lesion in the kidney (bilateral RCC is acceptable), stage I (T1 – both T1a and T1b) of the disease (tumor <7 cm in diameter), T1a/b N0 M0
- ECOG performance status ≤2
- Medically operable
- Signed informed consent for study participation
- Multidisciplinary decision confirming the need for active treatment
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test in the screening process. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Simplified exclusion criteria:
- The presence of an oncocytoma, angiomyolipoma, or other benign tumor in the postoperative histopathological examination does not require imaging follow-up for apparent reasons.
- Prior systemic therapies for RCC .
- Individuals with prior kidney cancer treatments, multiple tumors in the same kidney, or those with metastatic or recurrent disease.
- Pre-treatment estimated glomerular filtration rate <30mls/min
- Previous high-dose radiotherapy to an overlapping region (defined as BED >40Gy using an α/β ratio of 10)
- Untreated active prior malignancy within 3 years of screening (except for localised prostate cancer, in situ cervical cancer, basal cell carcinoma)
- Horseshoe kidney
Contact
Clinical trial coordinator
Paulina Ciesińska
e-mail: paulina.ciesinska@cm.umk.pl
Project Manager
Julia Barańska
e-mail: julia.baranska@cm.umk.pl
Agnieszka Ciesińska
e-mail: agnieszka.ciesinska@cm.umk.pl