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

Sponsor

Consorci Sanitari de Terrassa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05817604

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cancer cell (RCC) in medically inoperable patients. Although large prospective studies are lacking, we report our institutional database of primary RCC treated with SBRT.

Condition or Disease	Intervention/Treatment	Phase
Kidney Neoplasm Renal Cancer Inoperable Disease	Radiation: SBRT

Detailed Description

Consecutive patients treated with curative intent to evaluate oncological outcomes and renal function for patients diagnosed with Primary Renal Cancer Cell [Size <7cm (cT1b)] based on TC, MRI or PET Image Study. Multifraction SBRT13Gyx3 fraction-squeme is proposed. Treatment-related toxicity is evaluated acording to CTCAE v5.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Localized Renal Cancer Stereotatic Body Radiotherapy (SBRT) 13Gyx3 fraction-squeme for Medically Inoperable Localized Renal Cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study.	Radiation: SBRT SBRT dose 13Gyx3 fraction-squeme

Arm

Intervention/Treatment

Localized Renal Cancer

Stereotatic Body Radiotherapy (SBRT) 13Gyx3 fraction-squeme for Medically Inoperable Localized Renal Cancer [Size <7cm (cT1b)] based on TC, MRI or PET Image Study.

Radiation: SBRT

SBRT dose 13Gyx3 fraction-squeme

Outcome Measures

Primary Outcome Measures

Local Control [Participants should be followed continuously during 5 years]
Local Control assessed by RECIST criteria with TC, MRI or PET-scan

Secondary Outcome Measures

Metastases-Free Survival [Participants should be followed continuously during 5 years]
Metastases-Free Survival assessed by RECIST criteria with TC, MRI or PET-scan
Overall Survival [Participants should be followed continuously during 5 years]
Defined as the time from diagnose to the date of death from any cause.
Renal treatment-related adverse events [Participants should be followed continuously during 5 years]
Specific Renal Function-related adverse events measured by Glomerular Filtration Rate
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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