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Clinical Trials in Spain / NCT05817604
Active, not recruiting Observational

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

NCT05817604 · tracked via the Priya Life Science Spain tracker
Sponsor
Consorci Sanitari de Terrassa
Phase
Observational
Started
2023-03-01
Last updated
2024-05-10

Condition(s) studied

Kidney NeoplasmRenal CancerInoperable DiseaseSBRTSABR

Investigational drug(s) / intervention(s)

SBRT

SBRT: Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.

Study summary

Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Local relapse-free survival — Participants should be followed continuously during 5 years
    Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan

Trial sites (1)

FacilityCityRegionStatus
Consorci Sanitari de Terrassa Terrassa Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05817604 on ClinicalTrials.gov ↗ ← All trials in Spain