Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors

Study Overview
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Brief Summary
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Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cancer cell (RCC) in medically inoperable patients. Although large prospective studies are lacking, we report our institutional database of primary RCC treated with SBRT.

Detailed Description
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Consecutive patients treated with curative intent to evaluate oncological outcomes and renal function for patients diagnosed with Primary Renal Cancer Cell [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. Multifraction SBRT13Gyx3 fraction-squeme is proposed. Treatment-related toxicity is evaluated acording to CTCAE v5.

Official Title
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Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA)

Conditions
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Kidney Neoplasm, Renal Cancer, Inoperable Disease

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET. Tumor Diameter >1cm - <7cm Tumor visible on CT planning Medically inoperable disease (or rejection of surgery) Karnofsky Index >70% >18 y.o. Informed Consent signature Exclusion criteria: Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy. Previous local/regional RT Life expectancy <6 months Concomitance with other antineoplastic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Localized Renal Cancer<br>Stereotatic Body Radiotherapy (SBRT) 13Gyx3 fraction-squeme for Medically Inoperable Localized Renal Cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. | Radiation: SBRT<br>* SBRT dose 13Gyx3 fraction-squeme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control | Local Control assessed by RECIST criteria with TC, MRI or PET-scan | Participants should be followed continuously during 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastases-Free Survival | Metastases-Free Survival assessed by RECIST criteria with TC, MRI or PET-scan | Participants should be followed continuously during 5 years | 
| Overall Survival | Defined as the time from diagnose to the date of death from any cause. | Participants should be followed continuously during 5 years | 
| Renal treatment-related adverse events | Specific Renal Function-related adverse events measured by Glomerular Filtration Rate | Participants should be followed continuously during 5 years | 
| Non-Renal treatment-related adverse events | Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0 | Participants should be followed continuously during 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, SBRT, Renal Cancer, Primary Localized Renal Cancer, Inoperable Cancer, Kidney Neoplasm