Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
- Conditions
- Liver Metastasis Colon CancerKidney CancerLiver CancerRenal Cell Carcinoma
- Interventions
- Procedure: Microwave ablation (MWA)
- Registration Number
- NCT03981497
- Lead Sponsor
- Francesco De Cobelli
- Brief Summary
The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA.
Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path
- Detailed Description
Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- > 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone
- Primary liver cancer: up to three liver nodules ≤ 3 cm
- Secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), < 4 cm
- pregnant women
- non-manageable coagulopathies
- Extended extrahepatic or extrarenal disease
- for liver ablation: presence of bilio-digestive anastomosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Small Renal Tumors Microwave ablation (MWA) Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA Primary and Secondary Liver cancer Microwave ablation (MWA) Primary liver tumors: subjects who are candidates for MWA with nodules ≤ 3 cm Liver metastases: subjects who are candidates for MWA with nodules less than ≤ 3 cm
- Primary Outcome Measures
Name Time Method Time to Local Progression From date of ablation until death from any cause; evaluated up to 5 years Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Local Tumor Progression Free Survival From date of ablation until death from any cause; evaluated up to 5 years Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From date of ablation until death from any cause; evaluated up to 5 years From date of ablation until death for any cause
Organ specific Progression Free Survival (PFS) From date of ablation until death from any cause; evaluated up to 5 years From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)
Progression Free Survival (PFS) From date of ablation until death from any cause; evaluated up to 5 years From date of ablation until any documented evidence of tumor progression at any site
Trial Locations
- Locations (1)
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy