Spots Global Cancer Trial Database for SAbR For Oligometastatic Renal Cell Carcinoma

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Trial Identification

Brief Title: SAbR For Oligometastatic Renal Cell Carcinoma

Official Title: Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma

Study ID: NCT02956798

Conditions

Oligometastatic Renal Cell Carcinoma

Interventions

Stereotactic ablative body radiation (SABR)

Study Description

Brief Summary: 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).

Detailed 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 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.