Actively Recruiting
Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
Led by Istituto Clinico Humanitas · Updated on 2026-01-21
53
Participants Needed
2
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study objective is to evaluate the use of Stereotactic Body Radiotherapy (high dose of radiation in a few fractions) to cure primary renal cancer in those patients that are not indicated to surgery (high risk of complications, refusal of the patient). This therapy is already used in clinical setting for many tumors with good tolerance as it is not invasive, does not require anesthesia and hospitalization making it suitable for elderly people and frail patients. However there are not enough information regarding the use of ablative doses for the cure of renal cancer and for this reason this study aims to support the use of Stereotactic Body Radiotherapy as a standard of care for inoperable primary renal tumor. This is an observational study, so it collects data from clinical pratice only and does not request study specific procedures.
CONDITIONS
Official Title
Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- ECOG performance status 0 - 2
- Histologically confirmed diagnosis of primary RCC
- cT1 stage tumor with single lesion with maximum diameter of 7 cm
- Medically inoperable or at high risk of complication from surgery, or declined surgery
- Absence of metastatic disease
- Written informed consent
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) < 30 mls/min
- Previous radiotherapy on the same site
- Previous systemic therapy for RCC
- Tumor diameter larger than 7 cm
- Presence of metastatic disease
- Life expectancy < 3 months
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Humanitas PIO X
Milan, Milan, Italy, 20159
Not Yet Recruiting
2
Irccs Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
Research Team
C
Ciro Franzese, MD, radiation oncologist
CONTACT
L
Laura Bonavita, Master's degree
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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