NRG-GU012 (Renal Cell Carcinoma)

What is the Purpose of this Study?

We are doing this study to find out if adding radiation therapy has any positive benefit when it is added to the usual treatment regimen for this form of cancer.

What is the Condition Being Studied?

Metastatic or Unresectable Renal Cell Cancer

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with renal cell cancer that is metastatic (spread beyond the kidney) or unresectable (cannot be removed by surgery).

For more information, contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group 1: If you are in this group, you will get the usual immune therapy used to treat this type of cancer. You will get the immune therapy as an infusion through a vein in the arm, and if you also receive a VEGF drug, you will receive this as a pill you take by mouth
  • Group 2: If you are in this group, you will receive radiation therapy plus the usual immune therapy used to treat this type of cancer as described above. The radiation treatments will be given on 3 different days over the course of 1-3 weeks.

Study Details

Full Title
NRG-GU012: RANDOMIZED PHASE II STEREOTACTIC ABLATIVE RADIATION THERAPY (SABR) FOR METASTATIC UNRESECTED RENAL CELL CARCINOMA (RCC) RECEIVING IMMUNOTHERAPY (SAMURAI)
Principal Investigator
Assistant Professor of Radiation Oncology
Protocol Number
IRB: PRO00117320
NCT: NCT05327686
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL