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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Humanitas PIO X
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
IRCCS Humanitas Research Hospital
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.