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

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Renal Cancer

Treatments: Radiation: Stereotactic body radiotherapy (SBRT)

Study type: Observational

Funder types: Other

Identifiers

NCT07299357

STONE TRIAL

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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