NCT02455843

Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC

A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, open-label Phase III trial that compares microwave plus chemotherapy versus chemotherapy in patients with advanced non-small cell lung cancer. The primary endpoint is progression free survival (PFS) and the key secondary endpoint is overall survival (OS). A total of 275 eligible patients will be randomized to receive either microwave ablation combinated with first-line platinum-based doublet chemotherapy（138） or first-line platinum-based doublet chemotherapy（137） in a 1:1 ratio until patients. The response of microwave ablation will be assessed by the expert consensus for thermal ablation of primary and metastatic lung tumors. Tumor response and progression will be assessed according to Response Evaluation Criteria in Solid Tumors（RECIST）1.1.

Detailed description

Patients will be randomized to treated with microwave ablation and chemotherapy or treated with chemotherapy alone.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Microwave ablation	Patients assigned to the combination group will be treated with microwave in the primary tumor site

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-05-28
• Last updated: 2017-09-19

Locations

14 sites across 1 country: China