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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Ryan
Fecteau
Protocol Number
PRO00117320
NCT ID
NCT05327686
Phase
II
Enrollment Status
Open to Enrollment