MedDataX Logo

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

NCT ID: NCT07299357

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2033-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

renal cancer stereotactic body radiotherapy radiotherapy cancer treatment renal cancer treatment surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stereotactic body radiotherapy (SBRT)

high dose radiation in few fractions

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Humanitas PIO X

Milan, Milan, Italy

Site Status NOT_YET_RECRUITING

Irccs Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ciro Franzese, MD, radiation oncologist

Role: CONTACT

Phone: +39 0282247454

Email: [email protected]

Laura Bonavita, Master's degree

Role: CONTACT

Phone: +390282247026

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marco Badalamenti, MD, Radiation Oncologist

Role: primary

Ciro Franzese, MD, Radiation Oncologist

Role: primary

Laura Bonavita, Master's degree

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 38423047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36400098 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STONE TRIAL

Identifier Type: -

Identifier Source: org_study_id