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

Recruitingn/aAges 18 Years - anyAllIstituto Clinico Humanitas
NCT07299357 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 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 Exclusion Criteria: * 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
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What it tests

  • Stereotactic body radiotherapy (SBRT)
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Where

2 sites
Humanitas PIO X
Milan, Italy
Irccs Humanitas Research Hospital
Rozzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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