Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Renal Cell Carcinoma Clinical Trial

Official title:

Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981497
• Other study ID #: MWA-01
• Status: Recruiting
• Start date: February 28, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Francesco De Cobelli, MD
• Phone: +390226432529
• Email: decobelli.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 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

Exclusion Criteria:

• pregnant women
• non-manageable coagulopathies
• Extended extrahepatic or extrarenal disease
• for liver ablation: presence of bilio-digestive anastomosis

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Liver Cancer
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasms
• Renal Cell Carcinoma

Intervention

Procedure:
• Microwave ablation (MWA)
Thermal ablation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Francesco De Cobelli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

De Cobelli F, Marra P, Ratti F, Ambrosi A, Colombo M, Damascelli A, Sallemi C, Gusmini S, Salvioni M, Diana P, Cipriani F, Venturini M, Aldrighetti L, Del Maschio A. Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. Med Oncol. 2017 Apr;34(4):49. doi: 10.1007/s12032-017-0903-8. Epub 2017 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tumor Progression Free Survival	Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)	From date of ablation until death from any cause; evaluated up to 5 years
Primary	Time to Local Progression	Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)	From date of ablation until death from any cause; evaluated up to 5 years
Secondary	Overall Survival (OS)	From date of ablation until death for any cause	From date of ablation until death from any cause; evaluated up to 5 years
Secondary	Progression Free Survival (PFS)	From date of ablation until any documented evidence of tumor progression at any site	From date of ablation until death from any cause; evaluated up to 5 years
Secondary	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)	From date of ablation until death from any cause; evaluated up to 5 years