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

ConditionRenal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

Treatment groups

No treatment groups listed

Sponsors and collaborators