Phase III Study Comparing Standard Systemic Treatment Alone Versus Combined With Stereotactic Body Radiotherapy in Patients With Oligometastatic Renal Cell Carcinoma

What this Trial Is About

Researchers are investigating whether adding locoregional radiotherapy to standard systemic therapy improves progression-free survival in patients with oligometastatic renal cell carcinoma, which means kidney cancer with a limited number of metastases. This phase III randomized study aims to clarify if high-dose radiotherapy targeting metastases can better control the disease compared to systemic therapy alone. The trial includes patients with specific metastatic profiles, including new, recurrent, or induced metastases, to evaluate oncologic outcomes more precisely. Participants are divided into two groups one receives only standard systemic treatment, which may include targeted therapy, immunotherapy, or monotherapy with cancer drugs. The other group receives the same systemic treatment plus stereotactic ablative body radiotherapy SBRT directed at all metastatic lesions, typically given over one to two weeks with one to five sessions per region. This approach allows researchers to compare the effects of adding focused radiotherapy on disease progression. During the study, participants will be closely monitored through various assessments such as imaging and lab tests to track treatment effects and potential side effects. The main outcome measured is the one-year progression-free survival rate after completing enrollment. Additionally, researchers will evaluate local control at radiation sites, adverse events at different time points, and overall survival up to 36 months. The studys duration and follow-up ensure comprehensive data collection on treatment impact and safety.

Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma