NCT00922948
Withdrawn
Phase 2
A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
ConditionsRenal Cancers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Renal Cancers
- Sponsor
- St. Joseph's Healthcare Hamilton
- Locations
- 1
- Primary Endpoint
- Treatment failure rate.
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.
Detailed Description
By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.
Investigators
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton
Eligibility Criteria
Inclusion Criteria
- •Patients with tumors that progress in size while on a watchful waiting protocol;
- •Patients with multiple tumors;
- •Patients with a tumor in a solitary kidney;
- •Patients with poor renal function and a renal tumor;
- •Patients with significant co-morbidities that may benefit from a less invasive approach.
Exclusion Criteria
- •Large tumors \> 4.0cm;
- •Unable to have a general anesthetic;
- •Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
- •Uncorrectable bleeding diathesis;
- •Evidence of metastatic disease.
Outcomes
Primary Outcomes
Treatment failure rate.
Time Frame: Baseline, Weeks 6, 12, 24, 36, 48
Secondary Outcomes
- Quality of life data.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Average percentage decrease in tumor size.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Intra and post-operative complications rates.(Weeks 6, 12, 24, 36 and 48)
Study Sites (1)
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