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

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

NCT ID: NCT05817604

Condition: Kidney Neoplasm
Renal Cancer
Inoperable Disease
SBRT
SABR

Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell

Conditions: Keywords:
Stereotactic Body Radiotherapy
Renal Cancer
Primary Localized Renal Cancer
Kidney Neoplasm
Radiotherapy
Inoperable Cancer
Stereotactic ablative radiotherapy
SBRT
SABR

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: SBRT
Description: Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.
Arm group label: Localized Renal Cancer-One arm

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Consorci Sanitari de Terrassa

Address:
City: Terrassa
Zip: 08227
Country: Spain

Start date: March 1, 2023

Completion date: May 1, 2028

Lead sponsor:
Agency: Consorci Sanitari de Terrassa
Agency class: Other

Source: Consorci Sanitari de Terrassa

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05817604