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NCT Number: NCT05817604

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inoperable Disease Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer SABR SBRT Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Local relapse-free survival

    Time frame: Participants should be followed continuously during 5 years

    Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan

Secondary outcomes

  1. Metastases-Free Survival

    Time frame: Participants should be followed continuously during 5 years

    Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan

  2. Overall Survival

    Time frame: Participants should be followed continuously during 5 years

    Defined as the time from diagnose to the date of death from any cause.

  3. Cancer Specific Survival

    Time frame: Participants should be followed continuously during 5 years

    Defined as the time from diagnose to the date of death from renal cancer.

  4. Renal treatment-related adverse events

    Time frame: Participants should be followed continuously during 5 years

    Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate

  5. Non-Renal treatment-related adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Acronym: SABINA

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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