Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses

Not Applicable

• Conditions: Small Renal Masses (SRM)
• Interventions: Procedure: Radiofrequency Ablation; Radiation: Stereotactive body radiation therapy

• Registration Number: NCT03811665
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Study Start: 2019-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation (RFA)	Radiofrequency Ablation	-
Stereotactic body radiation therapy (SBRT)	Stereotactive body radiation therapy	-

Primary Outcome Measures

Name	Time	Method
Treatment failure	12 Months	Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.
Overall Survival	12 Months	Defined as post-procedural survival.
Disease free survival	12 Months	Defined as disease-free survival rate after a single procedure
Disease recurrence	12 Months	Defined as disease recurrence rate after a single procedure, including positive biopsy result.

Secondary Outcome Measures

Name	Time	Method
Tumour Size	12 Months	Average percentage decrease in tumor size.
Renal Function -eGFR	12 Months	Change in eGRF measured by mL/min/1.73m2.
Renal Function - Serum Creatinine	12 Months	Change in serum creatinine level measured by umol/L.
Renal Function - Creatinine Clearance	12 Months	Change in creatinine clearance measured by ml/minute.
Complication Rate	12 Months	Intra and post intervention complication rates will be documented in terms of nausea, vomiting, diarrhea, hematuria, hemorrhage (requiring or not requiring transfusion), perinephric hematoma, ureteral strictures, loss of a renal unit, urinary leak, bleeding, fever and flulike symptoms, stomach/bowel ulceration, ureteropelvic junction obstruction, and upper pole hydrocalycosis.
Change in score for quality of life	12 Months	Defined by the generic EuroQol (EQ-5D) questionnaire that is a standardized measure of health. A scale of 0-100 (0 being the worse health, and 100 being the best health), is used for a patient to define their overall health and wellbeing.
Duration of hospital stay	Days	Duration of length of hospital stay (if applicable)
Number of patients that experienced an adverse event.	12 Months	Defined by any adverse event listed in the CTCAE.
Cost analysis	12 Months	Defined by total cost of procedure and any associated related adverse events post procedure.

Trial Locations

Locations (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada