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

A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Small Renal Masses (SRM)
• Intervention / Treatment: Radiation: Stereotactive body radiation therapy; Procedure: Radiofrequency Ablation

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stereotactic body radiation therapy (SBRT)	Radiation: Stereotactive body radiation therapy; The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV.; Other Names: SBRT
ACTIVE_COMPARATOR: Radiofrequency Ablation (RFA)	Procedure: Radiofrequency Ablation; RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures.; Other Names: RFA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumour Size	Average percentage decrease in tumor size.	12 Months
Renal Function -eGFR	Change in eGRF measured by mL/min/1.73m2.	12 Months
Renal Function - Serum Creatinine	Change in serum creatinine level measured by umol/L.	12 Months
Renal Function - Creatinine Clearance	Change in creatinine clearance measured by ml/minute.	12 Months
Complication Rate	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.	12 Months
Number of patients that experienced an adverse event.	Defined by any adverse event listed in the CTCAE.	12 Months
Change in score for quality of life	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.	12 Months
Duration of hospital stay	Duration of length of hospital stay (if applicable)	Days
Cost analysis	Defined by total cost of procedure and any associated related adverse events post procedure.	12 Months

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Anil Kapoor, MD FRCSC, St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RADSTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No