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

NCT05817604 | Active Not Recruiting

• 1 other identifier: SABINA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Neoplasm; Renal Cancer; Inoperable Disease; SBRT; SABR

Keywords

Stereotactic Body Radiotherapy; Renal Cancer; Primary Localized Renal Cancer; Kidney Neoplasm; Radiotherapy; Inoperable Cancer; Stereotactic ablative radiotherapy; SBRT; SABR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Metastases-Free Survival

  Participants should be followed continuously during 5 years

• Overall Survival

  Participants should be followed continuously during 5 years

• Cancer Specific Survival

  Participants should be followed continuously during 5 years

• Renal treatment-related adverse events

  Participants should be followed continuously during 5 years

• Non-Renal treatment-related adverse events

  Participants should be followed continuously during 5 years

Study Arms (1)

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

Interventions

SBRT RADIATION

Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme. Tumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.

Localized Renal Cancer-One arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Manuel Galdeano-Rubio, MD

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, MD, MSc

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

ES (1)