NCT02956798

SAbR For Oligometastatic Renal Cell Carcinoma

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oligometastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic ablative body radiation (SABR)	SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Timeline

• Start date: 2018-07-19
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2016-11-07
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study