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Recruiting NCT07299357

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

— Observational Renal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic body radiotherapy (SBRT).
Who it may be relevant to
Registry conditions: Renal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation Stereotactic body radiotherapy (SBRT)
    high dose radiation in few fractions

Primary outcome measures

  • evaluate LC of treated lesions at 1 year [Time frame: from end of treatment to 1 year]
Secondary outcome measures (7)
  • to assess acute and late toxicity [Time frame: from start of treatment to 3 years]
  • To assess kidney function with serum creatinine [Time frame: from start of treatment to 3 years]
  • Progression Free Survival (PFS) [Time frame: from end of treatment to 1 year]
  • metastasis free survival [Time frame: from end of treatment to 3 years]
  • Overall Survival [Time frame: from end of treatment to 3 years]
  • To asses Quality of Life [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • Humanitas PIO X — Milan
  • Irccs Humanitas Research Hospital — Rozzano

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-ran PMID 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 Consort PMID 36400098
  • AIOM-AIRTUM. I numeri del cancro in Italia. Rapporto 2020. Disponibile sul sito: https://www.aiom.it/i-numeri-del-cancro-in-italia

Identifiers

NCT: NCT07299357 · STONE TRIAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗