SAbR For Oligometastatic Renal Cell Carcinoma

Summary

Participation Requirements

Description

The study is a prospective single institution phase II single-arm open-label trial evaluating SAbR in patients with newly diagnosed oligometastatic RCC. Problem Statements: Can local therapy (SAbR) safely delay the start of systemic therapy? Safely delaying the start of systemic therapy can have sig...

The study is a prospective single institution phase II single-arm open-label trial evaluating SAbR in patients with newly diagnosed oligometastatic RCC. Problem Statements: Can local therapy (SAbR) safely delay the start of systemic therapy? Safely delaying the start of systemic therapy can have significant quality of life benefits for patients since systemic therapy has significant side effects. Can SAbR be curative in truly oligometastatic RCC patients? Primary Endpoint: • Time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to start of systemic therapy. Secondary Endpoint: Modified progression-free survival (mPFS) is defined as the survival interval without development of >3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of >6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis. Overall Survival Local control Toxicity HRQOL Sample Size: 23 Patients will be enrolled. Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

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