SAbR For Oligometastatic Renal Cell Carcinoma

Oligometastatic Renal Cell Carcinoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Oligometastatic Renal Cell Carcinoma

• NCT number: NCT02956798
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 19, 2018
• Completion date: December 31, 2024