A Phase II Study Evaluating Stereotactic Radiotherapy for Oligoprogressive Metastatic Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the use of stereotactic radiotherapy (SRT) as a treatment strategy for patients with oligoprogressive metastatic renal cell carcinoma (RCC) who are already undergoing systemic therapies. This phase II study focuses on patients whose cancer has progressed in a limited number of sites despite ongoing treatment, aiming to control local tumors and delay the need for additional systemic therapies. The study builds on evidence that SRT can effectively target RCC metastases and may also stimulate the immune system when combined with immunotherapy. The study involves delivering high-dose stereotactic radiotherapy to metastatic sites showing progression in patients receiving systemic therapies such as targeted drugs or immunotherapy. Eligible patients have 1 to 3 progressing metastases in up to 2 organs, with lesions measuring 4 cm or less, and will continue their current systemic treatment while receiving SRT either concurrently or sequentially. This approach aims to locally control progressing tumors and potentially extend the effectiveness of ongoing therapy. Participants will undergo imaging assessments to confirm disease progression and measure tumor response, with follow-up visits to monitor tumor control and treatment side effects. Researchers will evaluate progression-free survival six months after randomization as the primary outcome, along with local and overall control rates and treatment-related adverse events. The study includes monitoring for safety and effectiveness up to 12 months post-treatment, with participants' involvement lasting until at least one month after treatment completion.

A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases