Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses

St. Joseph's Healthcare Hamilton24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Small Renal Masses (SRM)

Interventions

Radiofrequency AblationPROCEDURE

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.

Stereotactive body radiation therapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Treatment failure

Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.

Time frame: 12 Months

Overall Survival

Defined as post-procedural survival.

Time frame: 12 Months

Disease free survival

Defined as disease-free survival rate after a single procedure

Time frame: 12 Months

Disease recurrence

Defined as disease recurrence rate after a single procedure, including positive biopsy result.

Time frame: 12 Months

Secondary Outcomes

Tumour Size

Average percentage decrease in tumor size.

Time frame: 12 Months

Renal Function -eGFR

Change in eGRF measured by mL/min/1.73m2.

Time frame: 12 Months

Renal Function - Serum Creatinine

Change in serum creatinine level measured by umol/L.

Time frame: 12 Months

Renal Function - Creatinine Clearance

Change in creatinine clearance measured by ml/minute.

Time frame: 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.

Data from ClinicalTrials.gov

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