Small Renal Masses (SRM) Clinical Trial
— SBRT vs RFAOfficial title:
A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.
| Verified date | December 2021 |
| Source | St. Joseph's Healthcare Hamilton |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 24 |
| Est. completion date | December 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| St. Joseph's Healthcare Hamilton |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment failure | Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast. | 12 Months | |
| Primary | Overall Survival | Defined as post-procedural survival. | 12 Months | |
| Primary | Disease free survival | Defined as disease-free survival rate after a single procedure | 12 Months | |
| Primary | Disease recurrence | Defined as disease recurrence rate after a single procedure, including positive biopsy result. | 12 Months | |
| Secondary | Tumour Size | Average percentage decrease in tumor size. | 12 Months | |
| Secondary | Renal Function -eGFR | Change in eGRF measured by mL/min/1.73m2. | 12 Months | |
| Secondary | Renal Function - Serum Creatinine | Change in serum creatinine level measured by umol/L. | 12 Months | |
| Secondary | Renal Function - Creatinine Clearance | Change in creatinine clearance measured by ml/minute. | 12 Months | |
| Secondary | 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 | |
| Secondary | Number of patients that experienced an adverse event. | Defined by any adverse event listed in the CTCAE. | 12 Months | |
| Secondary | 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 | |
| Secondary | Duration of hospital stay | Duration of length of hospital stay (if applicable) | Days | |
| Secondary | Cost analysis | Defined by total cost of procedure and any associated related adverse events post procedure. | 12 Months |