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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Cancer; Inoperable Disease; SBRT; Kidney Neoplasm; SABR
• Intervention / Treatment: Radiation: SBRT

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • Consorci Sanitari de Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Localized Renal Cancer-One arm; Patients diagnosed with medically inoperable localized renal cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study.	Radiation: SBRT; Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local relapse-free survival	Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan	Participants should be followed continuously during 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Defined as the time from diagnose to the date of death from any cause.	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
Metastases-Free Survival	Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan	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.	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	Participants should be followed continuously during 5 years

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa
• Investigators: Principal Investigator: Manuel Galdeano-Rubio, MD, Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; SBRT; Renal Cancer; Stereotactic Body Radiotherapy; SABR; Stereotactic ablative radiotherapy; Kidney Neoplasm; Primary Localized Renal Cancer; Inoperable Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: SABINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No