NCT07299357Recruiting
Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 53 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Kidney cancer
- NCT number
- NCT07299357
What you commit to
- Study type: Observational
- Planned participants: 53
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy on the same site
- Previous systemic therapy for RCC
Other illness
- Presence of metastatic disease
Lab values
- Estimated glomerular filtration rate (eGFR) \< 30 mls/min
Other
- Tumor diameter larger than 7 cm
- Life expectancy \< 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas PIO X Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.