Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFrancesco De Cobelli
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 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
Disqualifiers
pregnant women
non-manageable coagulopathies
Extended extrahepatic or extrarenal disease
for liver ablation: presence of bilio-digestive anastomosis
Trial population
Subjects with indication of laparoscopic or percutaneous ablation of primary or secondary liver tumors and small primary kidney tumors (according to ESMO guidelines). All patients will follow their normal therapeutic procedure and no examination will be added to what is already provided for in the normal management of patients suffering from these diseases.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Microwave ablation (MWA)
Procedure/SurgeryThermal ablation
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Small Renal Tumors1 intervention
Group B: Primary and Secondary Liver cancer1 intervention
Trial outcomes
Primary outcomes
1
Local Tumor Progression Free Survival
Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Time frame
From date of ablation until death from any cause; evaluated up to 5 years2
Time to Local Progression
Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Time frame
From date of ablation until death from any cause; evaluated up to 5 yearsSecondary outcomes
1
Overall Survival (OS)
From date of ablation until death for any cause
Time frame
From date of ablation until death from any cause; evaluated up to 5 years2
Progression Free Survival (PFS)
From date of ablation until any documented evidence of tumor progression at any site
Time frame
From date of ablation until death from any cause; evaluated up to 5 years3
Organ specific Progression Free Survival (PFS)
From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)
Time frame
From date of ablation until death from any cause; evaluated up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Francesco De Cobelli
Lead sponsor
IRCCS San Raffaele
Sponsor institution
Source ClinicalTrials.gov