Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Patients diagnosed with medically inoperable localized renal cancer \[Size \<7cm (cT1b)\] based on TC, MRI or PET Image Study.

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

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

SBRT

Manuel Galdeano-Rubio, MD

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.

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

Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan

Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan

Defined as the time from diagnose to the date of death from any cause.

Defined as the time from diagnose to the date of death from renal cancer.

Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate

Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)	NCT05817604	Kidney Neoplasm Renal Cancer Inoperable Dise... SBRT SABR	SBRT	18 Years - 100 Years	Consorci Sanitari de Terrassa
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)	NCT05817604	Kidney Neoplasm Renal Cancer Inoperable Dise... SBRT SABR	SBRT	18 Years - 100 Years	Consorci Sanitari de Terrassa
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)	NCT05817604	Kidney Neoplasm Renal Cancer Inoperable Dise... SBRT SABR	SBRT	18 Years - 100 Years	Consorci Sanitari de Terrassa
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)	NCT05817604	Kidney Neoplasm Renal Cancer Inoperable Dise... SBRT SABR	SBRT	18 Years - 100 Years	Consorci Sanitari de Terrassa

Spots Global Cancer Trial Database for primary localized renal cancer