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

Short Title: NRG-GU012


Enrollment Status: Recruiting

NCT #: NCT05327686

Specialty Area: Oncology

Condition Studied: Renal Cell Carcinoma

Age Groups: Adult; Older Adult

Phase: II


Study Information

Summary / Purpose

The purpose of this study is to compare whether the addition of radiation in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic).

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Confirmed diagnosis of renal cell carcinoma
  • Node-positive that cannot be removed by surgery (unresectable, TxN1Mx) or has spread to other parts of the body (metastatic, TxNxM1)
  • Patient not recommended for or declined immediate cytoreductive nephrectomy

What's Involved

Participation in the study will include:
  • Random assignment to receive standard of care immunotherapy alone, which may include drugs given by intravenous (IV) infusion and drugs taken by mouth, or standard of care immunotherapy plus stereotactic ablative radiation therapy (SABR) to the kidney tumor
  • Computed tomography (CT) or magnetic resonance imaging (MRI), and bone scans
  • Blood sample collection

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.