Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses (SBRT vs RFA)

St. Joseph's Healthcare Hamilton

Status: Unknown

Conditions: Small Renal Masses (SRM)

Treatments: Radiation: Stereotactive body radiation therapy; Procedure: Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03811665

RADSTER

Details and patient eligibility

About

The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years of age and capable of providing informed consent
• Patients scheduled for treatment of their SRM using SBRT or RFA
• Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
• Patients who are willing to have a biopsy 12 months post-procedure
• Patients with renal tumor(s) ≤ 4.0 cm

Exclusion criteria

• Patients with large renal tumor(s)>4.0 cm
• Patients who are unable to have a general anesthetic
• Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
• Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
• Evidence of metastatic disease
• Uncorrectable bleeding diathesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Stereotactic body radiation therapy (SBRT)

Experimental group

Treatment:

Radiation: Stereotactive body radiation therapy

Radiofrequency Ablation (RFA)

Active Comparator group

Treatment:

Procedure: Radiofrequency Ablation