NRG-GU012: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
About this trial
The Samurai is currently open at:
- St. Luke’s Radiation Oncology Network (SLRON)
- Beacon Hospital
What is the goal of this study?
This study aims to find out whether adding stereotactic ablative radiotherapy (SABR) to the kidney tumour can improve outcomes for people with metastatic renal cell carcinoma (kidney cancer which has already spread beyond the kidney) who are already receiving standard immune therapy.
Researchers want to learn whether treating the main kidney tumour with precise, high-dose radiotherapy can help:
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better control the cancer,
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improve how well immune therapy works,
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delay cancer growth, and
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still remain safe and tolerable for patients.
The study compares immune therapy alone (standard of care) with immune therapy plus SABR to see which approach works best.
This video explains the Samurai Study:
What happens to patients as part of this trial?
All patients receive the usual immune therapy for metastatic kidney cancer.
A computer randomly assigns participants to one of two groups:
Arm 1 (Standard/Control Group)
You receive the standard immune therapy only.
Arm 2 (Radiation Group)
You receive the same immune therapy, plus a short course of SABR targeted at the kidney tumour.
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SABR uses a small number of treatment sessions, each delivering a very precise, high dose of radiation to the tumour.
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Treatment is highly focused to limit exposure to nearby organs.
This video explains more about what SABR treatment is.
Appointment Schedule and Tests
If you join the study, you will attend regular hospital visits for:
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physical exams,
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blood tests,
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scans (CT or MRI),
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symptom checks,
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and follow-up appointments after treatment.
These are similar to the usual care for metastatic kidney cancer.
Who can take part?
You may be eligible if:
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You are 18 years or older.
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You have metastatic or node-positive renal cell carcinoma that has not been removed by surgery.
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You are not suitable for, or have decided against, immediate removal of the kidney tumour.
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Your cancer is clear cell or non-clear cell type, and meets certain medical risk-group criteria (your doctor will be able to inform you about this)
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You have at least one area of cancer outside the kidney that can be measured on scans.
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You are well enough for immune therapy and meet required kidney, liver, and blood test levels.
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You can attend regular hospital appointments and follow-up visits.
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You are willing to use effective contraception if required.
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Study Oversight
Professor Alina Mihai is the Chief Investigator of the study in Ireland.
The study is sponsored nationally by Cancer Trials Ireland.
NRG Oncology in the US are the international study sponsors and Professor William A Hall is the Sponsor-Investigator.