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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• evaluate LC of treated lesions at 1 year [Срок оценки: from end of treatment to 1 year]

Вторичные конечные точки (7)

• to assess acute and late toxicity [Срок оценки: from start of treatment to 3 years]
• To assess kidney function with serum creatinine [Срок оценки: from start of treatment to 3 years]
• Progression Free Survival (PFS) [Срок оценки: from end of treatment to 1 year]
• metastasis free survival [Срок оценки: from end of treatment to 3 years]
• Overall Survival [Срок оценки: from end of treatment to 3 years]
• To asses Quality of Life [Срок оценки: from start of treatment to 3 years]
• To assess kidney function with estimated glomerular filtration rate [Срок оценки: from start of treatment to 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• Humanitas PIO X — Milan
• Irccs Humanitas Research Hospital — Rozzano

Публикации

• 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

Идентификаторы

NCT: NCT07299357 · STONE TRIAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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