Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer
Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer. Participants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme. Assesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR. Follow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.
Study Type
OBSERVATIONAL
Enrollment
60
Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Local relapse-free survival
Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Time frame: Participants should be followed continuously during 5 years
Metastases-Free Survival
Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Time frame: Participants should be followed continuously during 5 years
Overall Survival
Defined as the time from diagnose to the date of death from any cause.
Time frame: Participants should be followed continuously during 5 years
Cancer Specific Survival
Defined as the time from diagnose to the date of death from renal cancer.
Time frame: Participants should be followed continuously during 5 years
Renal treatment-related adverse events
Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate
Time frame: 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
Time frame: Participants should be followed continuously during 5 years
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