RecruitingNCT07299357

Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial


Sponsor

Istituto Clinico Humanitas

Enrollment

53 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a precise, non-surgical radiation treatment called stereotactic body radiation therapy (SBRT) for people with early-stage kidney cancer who cannot or do not want to have surgery. Researchers want to learn how well this targeted radiation approach works and how safe it is. **You may be eligible if...** - You are 18 or older - You have been diagnosed with kidney cancer (renal cell carcinoma) confirmed by a biopsy - Your tumor is in an early stage (cT1), is a single lesion, and is no larger than 7 cm - Your doctors consider surgery too risky, or you have decided not to have surgery - Your cancer has not spread to other parts of your body - Your kidneys are functioning reasonably well (eGFR of 30 or higher) **You may NOT be eligible if...** - Your kidneys are functioning poorly (eGFR below 30) - You have already had radiation therapy on the same area - You have previously received systemic (drug) treatment for kidney cancer - Your tumor is larger than 7 cm - Your cancer has spread to other parts of your body - Your life expectancy is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiotherapy (SBRT)

high dose radiation in few fractions


Locations(2)

Humanitas PIO X

Milan, Milan, Italy

Irccs Humanitas Research Hospital

Rozzano, Milan, Italy

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NCT07299357


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