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Brief Title: Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
Official Title: A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
Study ID: NCT02455843
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Binzhou Medical University Hospital, Binzhou, Shandong, China
Dezhou People's Hospital, Dezhou, Shandong, China
The Second People's Hospital of Dezhou, Dezhou, Shandong, China
Jinan Military General Hospital, Jinan, Shandong, China
Affliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China
Shandong Provincial Hospital, Jinan, Shandong, China
Affliated Hospital of Jining Medical University, Jining, Shandong, China
Liaocheng Cancer Hospital, Liaocheng, Shandong, China
The People's Hospital of Pingyi Country, Linyi, Shandong, China
Affliated Hospital of Taishan Medical University, Taian, Shandong, China
The People's Liberation Army 88 Hospital, Taian, Shandong, China
Weifang People's Hospital, Weifang, Shandong, China
Yantai Yuhuangding Hospital, Yantai, Shandong, China
Tengzhou center of people's hospital, Zaozhuang, Shandong, China
Name: Kai x Zhang, M.D
Affiliation: Tengzhou Center of People's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jing w Bi, M.D.
Affiliation: Jinan Military General Hospital
Role: PRINCIPAL_INVESTIGATOR