Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses
NCT ID: NCT03811665
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2019-10-01
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Stereotactic body radiation therapy (SBRT)
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.
Radiofrequency Ablation (RFA)
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Anil Kapoor
Principal Investigator
Principal Investigators
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Anil Kapoor, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Locations
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McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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Cassim R, Bansal R, Millan B, Mironov O, Ahir P, Tajzler C, Hoogenes J, Matsumoto ED, Quan K, Kapoor A, Swaminath A. A Randomized Trial of Stereotactic Body Radiation Therapy vs Radiofrequency Ablation for the Treatment of Small Renal Masses: A Feasibility Study (RADSTER). Urology. 2025 Jun;200:118-124. doi: 10.1016/j.urology.2025.02.053. Epub 2025 Mar 7.
Other Identifiers
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RADSTER
Identifier Type: -
Identifier Source: org_study_id