Oligometastatic Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Hypothesis: Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy. Primary Objectives: • To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy. Secondary Objective: - To evaluate the modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. - To evaluate the overall survival (OS) - To evaluate the cancer specific survival (CSS) - To evaluate the local control rate of irradiated lesions. - To measure the health-related quality of life (HRQOL).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
|
Phase 2 | |
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