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

January 19, 2026 updated by: Istituto Clinico Humanitas
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient with renal cancer not candidate to surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate LC of treated lesions at 1 year
Time Frame: from end of treatment to 1 year
local progression is defined as an enlargement of at least 20% relative and 5 mm absolute increase of sum of diameters of target lesions compared to baseline at least after 6 months from treatment end
from end of treatment to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess acute and late toxicity
Time Frame: from start of treatment to 3 years
evaluate the presence of toxicities to treatment according to CTCAE 4.03
from start of treatment to 3 years
Progression Free Survival (PFS)
Time Frame: from end of treatment to 1 year
to asses through standard imaging according to clinical practice - The length of time during and after the treatment of cancer that a patient lives with the disease but it does not get worse
from end of treatment to 1 year
metastasis free survival
Time Frame: from end of treatment to 3 years
to asses through standard imaging according to clinical practice - The length of time from the start of treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body
from end of treatment to 3 years
Overall Survival
Time Frame: from end of treatment to 3 years
to asses through standard imaging according to clinical practice - The length of time from the start of cancer treatment during which patients diagnosed with the disease are still alive.
from end of treatment to 3 years
To assess kidney function with serum creatinine
Time Frame: from start of treatment to 3 years
evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)
from start of treatment to 3 years
To asses Quality of Life
Time Frame: from start of treatment to 3 years
Through QLQ-C30 questionnarie we will evaluate quality of life, patient will answer different questions crossing the number that is more suitable regarding their condition (the patient can respond by crossing a number from 1 to 4, 1 = excellent quality of life, 4 = terrible quality of life)
from start of treatment to 3 years
To assess kidney function with estimated glomerular filtration rate
Time Frame: from start of treatment to 3 years
evaluating eGFR at each follow up visit through blood analysis (ml/min)
from start of treatment to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STONE TRIAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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