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Renal CancerNCT07299357

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

An observational study of Renal Cancer, run by Istituto Clinico Humanitas at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cancer
What is being tested?
Stereotactic body radiotherapy (SBRT)
Type of treatment
Surgery or procedure
How many people
53 participants
Where
2 sitesItaly
Study dates
Jan 2026to Dec 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patient with renal cancer not candidate to surgery

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ciro Franzese, MD, radiation oncologist contact

+39 0282247454

ciro.franzese@hunimed.eu

Laura Bonavita, Master's degree contact

+390282247026

laura.bonavita@humanitas.it

Italy2 sites, 2 recruiting

  • Humanitas PIO X

    Milan, Milan, 20159

    Marco Badalamenti, MD, Radiation Oncologist, marco.badalamenti@cancercenter.humanitas.it

    Not yet recruiting

  • Irccs Humanitas Research Hospital

    Rozzano, Milan, 20089

    Ciro Franzese, MD, Radiation Oncologist, +39 0282247454, ciro.franzese@hunimed.eu

    Laura Bonavita, Master's degree, +39 0282247026, laura.bonavita@humanitas.it

    Recruiting

Other trials in Italy

About this study

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.

Conditions
Renal Cancer
Being tested
Stereotactic body radiotherapy (SBRT)
Keywords
renal cancer, stereotactic body radiotherapy, radiotherapy, cancer treatment, renal cancer treatment, surgery
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic body radiotherapy (SBRT)Radiation

    high dose radiation in few fractions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluate LC of treated lesions at 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

    Measured: from end of treatment to 1 year

Secondary outcomes (7)

  1. to assess acute and late toxicity

    evaluate the presence of toxicities to treatment according to CTCAE 4.03

    Measured: from start of treatment to 3 years

  2. To assess kidney function with serum creatinine

    evaluating serum creatinine at each follow up visit through blood analysis (mg/dL)

    Measured: from start of treatment to 3 years

  3. Progression Free Survival (PFS)

    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

    Measured: from end of treatment to 1 year

  4. metastasis free survival

    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

    Measured: from end of treatment to 3 years

  5. Overall Survival

    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.

    Measured: from end of treatment to 3 years

  6. To asses Quality of Life

    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)

    Measured: from start of treatment to 3 years

  7. To assess kidney function with estimated glomerular filtration rate

    evaluating eGFR at each follow up visit through blood analysis (ml/min)

    Measured: from start of treatment to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299357
Sponsor's protocol ID
STONE TRIAL
Status last verified
Jan 2026
First submitted
10 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.

    PubMed 38423047

  • Siva S, Ali M, Correa RJM, Muacevic A, Ponsky L, Ellis RJ, Lo SS, Onishi H, Swaminath A, McLaughlin M, Morgan SC, Cury FL, Teh BS, Mahadevan A, Kaplan ID, Chu W, Grubb W, Hannan R, Staehler M, Warner A, Louie AV. 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Lancet Oncol. 2022 Dec;23(12):1508-1516. doi: 10.1016/S1470-2045(22)00656-8. Epub 2022 Nov 16.

    PubMed 36400098

  • AIOM-AIRTUM. I numeri del cancro in Italia. Rapporto 2020. Disponibile sul sito: https://www.aiom.it/i-numeri-del-cancro-in-italia

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cancer, run by Istituto Clinico Humanitas at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ciro Franzese, MD, radiation oncologist (+39 0282247454, ciro.franzese@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate LC of treated lesions at 1 year (time frame: from end of treatment to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299357, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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