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

Renal Cancer Clinical Trial

— SABINA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817604
• Other study ID #: SABINA
• Status: Active, not recruiting
• Start date: March 1, 2023
• Est. completion date: May 1, 2028

Study information

• Verified date: May 2024
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Inoperable Disease
• Kidney Neoplasm
• Kidney Neoplasms
• Renal Cancer
• SBRT

Intervention

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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival	Defined as the time from diagnose to the date of death from any cause.	Participants should be followed continuously during 5 years
Secondary	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
Secondary	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
Secondary	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