NCT07299357 Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
| NCT ID | NCT07299357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Renal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 53 participants |
| Start Date | 2026-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 53 participants in total. It began in 2026-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07299357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07299357 currently recruiting?
Yes, NCT07299357 is actively recruiting participants. Contact the research team at ciro.franzese@hunimed.eu for enrollment information.
Where is the NCT07299357 trial being conducted?
This trial is being conducted at Milan, Italy, Rozzano, Italy.
Who is sponsoring the NCT07299357 clinical trial?
NCT07299357 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 53 participants.
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