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

Active, not recruiting

• Conditions: Renal Cancer; Inoperable Disease; Kidney Neoplasm; SBRT; SABR
• Interventions: Radiation: SBRT

• Registration Number: NCT05817604
• Lead Sponsor: Consorci Sanitari de Terrassa

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Localized Renal Cancer-One arm	SBRT	Patients diagnosed with medically inoperable localized renal cancer \[Size \<7cm (cT1b)\] based on TC, MRI or PET Image Study.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Participants should be followed continuously during 5 years	Defined as the time from diagnose to the date of death from any cause.
Cancer Specific Survival	Participants should be followed continuously during 5 years	Defined as the time from diagnose to the date of death from renal cancer.
Renal treatment-related adverse events	Participants should be followed continuously during 5 years	Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate
Metastases-Free Survival	Participants should be followed continuously during 5 years	Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan
Non-Renal treatment-related adverse events	Participants should be followed continuously during 5 years	Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain