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

Inclusion Criteria7

  • 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 Criteria6

  • 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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07299357


Related Trials