Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.

Eligibility criteria

Qualifiers

Histological or clinical diagnosis of primary or secondary kidney tumors

Patients aged ≥18 years

Signed informed consent

Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)

Disqualifiers

Patients aged < 18 years

Tumors > 10 cm

PS ECOG ≥3

Psychiatric or other disorders that may prevent the patient from signing informed consent

Trial design

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators