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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2028-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Kidney Neoplasm Renal Cancer Inoperable Disease SBRT SABR

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Localized Renal Cancer-One arm

Patients diagnosed with medically inoperable localized renal cancer \[Size \<7cm (cT1b)\] based on TC, MRI or PET Image Study.

SBRT

Intervention Type RADIATION

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

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

Interventions

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SBRT

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

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes