NRG-GU012

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) For Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (Samurai)

Principal Investigator

William Hall, MD

Status

Open to Accrual

Disease Site

Genitourinary [GU]

Other

Phase

II

Developmental Therapeutics

No

Primary Objective

Primary Objective:  

To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC).The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.

Secondary Objective:

• To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm.
• To assess the objective response rate (ORR) by iRECIST in each treatment arm.
• Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nrPFS2).
• Radiographic progression-free survival (rPFS) .
• To assess overall survival (OS) in each treatment arm.
• To assess the time to subsequent second-line therapy or death in each treatment arm.
• To assess the rate of cytoreductive nephrectomy in each treatment arm.
• To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression.
• To assess the ORR by RECIST version 1.1 and iRECIST in the primary renal mass. 

Patient Population

Pathologically proven diagnosis of renal cell carcinoma and are unresected metastatic.

Target Accrual

240