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

NCT07299357 | Recruiting

• 1 other identifier: STONE TRIAL
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Renal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (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

  from end of treatment to 1 year

Secondary Outcomes (7)

• to assess acute and late toxicity

  from start of treatment to 3 years

• To assess kidney function with serum creatinine

  from start of treatment to 3 years

• Progression Free Survival (PFS)

  from end of treatment to 1 year

• metastasis free survival

  from end of treatment to 3 years

• Overall Survival

  from end of treatment to 3 years

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

high dose radiation in few fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with renal cancer not candidate to surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (2)

Humanitas PIO X

Milan, Milan, 20159, Italy

NOT YET RECRUITING

Irccs Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 38423047 BACKGROUND

• 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.

  PMID: 36400098 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ciro Franzese, MD, radiation oncologist

CONTACT

+39 0282247454; ciro.franzese@hunimed.eu

Laura Bonavita, Master's degree

CONTACT

+390282247026; laura.bonavita@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2033
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (2)