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

RecruitingNAAges 18 Years - anyAllIRCCS San Raffaele
NCT07285538 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histological or clinical diagnosis of primary or secondary kidney tumors 2. Patients aged ≥18 years 3. Signed informed consent 4. Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions) 5. PS (ECOG) ≤2 6. No prior local radiotherapy 7. Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed) Exclusion Criteria: 1. Patients aged \< 18 years 2. Tumors \> 10 cm 3. PS ECOG ≥3 4. Psychiatric or other disorders that may prevent the patient from signing informed consent 5. Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder) 6. Pregnant women 7. Collagen diseases 8. Sjogren's syndrome
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What it tests

  • Stereotactic body radiotherapy (SBRT)
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Where

1 site
Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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