Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients will be randomized to treated with microwave ablation and chemotherapy or treated with chemotherapy alone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave plus chemotherapy | Experimental | In combination group, patients will be treated with microwave ablation in primary tumor sites followed by chemotherapy (For non-squamous cell lung cancer,patients will be treated with pemetrexed,500mg/m2, d1, ivdrip, or docetaxel,75mg/m2, d1, ivdrip or gemcitabine 1250mg/m2, d1 d8, ivdrip,or novelbine 25mg/m2 d1 d8, ivdrip, paclitaxel 175mg/m2 d1 ivdrip plus cisplatin 75mg/m2, d1 d2, ivdrip or carboplatin with an area under the curve of 5 d1 ivdrip. For squamous cell lung cancer,patients will be treated with docetaxel,75mg/m2, d1, ivdrip or gemcitabine 1250mg/m2, d1 d8, ivdrip plus cisplatin 75mg/m2, d1 d2, ivdrip or carboplatin with an area under the curve of 5 d1 ivdrip;repeated every 3 weeks and up to 6 cycles are administrated ) |
|
| chemotherapy | Placebo Comparator | In chemotherapy group,patients will be treated with chemotherapy alone(For non-squamous cell lung cancer,patients will be treated with pemetrexed,500mg/m2, d1, ivdrip plus cisplatin 75mg/m2, d1 d2, ivdrip or carboplatin with a area uder the curve of 5 d1 ivdrip. For squamous cell lung cancer,patients will be treated with docetaxel,75mg/m2, d1, ivdrip or gemcitabine 1250mg/m2, d1 d8, novelbine 25mg/m2 d1 d8, ivdrip, paclitaxel 175mg/m2 d1 ivdrip plus cisplatin 75mg/m2, d1 d2, ivdrip or carboplatin with an area under the curve of 5 d1 ivdrip;repeated every 3 weeks and up to 6 cycles are administrated ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation | Other | Patients assigned to the combination group will be treated with microwave in the primary tumor site |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | From the start of chemotherapy or ablation to the date of progression or death | up to 12 months after the last patient randomized |
Not provided
Not provided
Inclusion Criteria:
Diagnosis of advanced stage NSCLC (stage IIIB or IV) which is confirmed by histology or cytology methods.
Measurable disease other than the primary tumors site according to RECIST1.1.
Eastern Cooperative Oncology Group (ECOG) score of 0-2
Adequate organ function, defined as all of the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Ye, M.D | Contact | +86 0531-68773172 | yexintaian2014@163.com | |
| Zhi g Wei, M.D | Contact | +86 0531-68773171 | weizhigang321321@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kai x Zhang, M.D | Tengzhou Center of People's Hospital | Principal Investigator |
| Jing w Bi, M.D. | Jinan Military General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Binzhou Medical University Hospital | Recruiting | Binzhou | Shandong | +86 256600 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25572816 | Result | Wei Z, Ye X, Yang X, Huang G, Li W, Wang J, Han X. Microwave ablation plus chemotherapy improved progression-free survival of advanced non-small cell lung cancer compared to chemotherapy alone. Med Oncol. 2015 Feb;32(2):464. doi: 10.1007/s12032-014-0464-z. Epub 2015 Jan 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 20, 2019 | |
| Reset | Apr 17, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2019 | Apr 17, 2019 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Patients were divided into two groups: The microwave ablation plus chemotherapy group and the chemotherapy group.The former will be treated with microwave, followed by chemotherapy.The latter will be treated with chemotherapy alone.
Not provided
Not provided
Not provided
Not provided
| Dezhou People's Hospital | Recruiting | Dezhou | Shandong | +86 253000 | China |
|
| The Second People's Hospital of Dezhou | Recruiting | Dezhou | Shandong | +86 253000 | China |
|
| Jinan Military General Hospital | Recruiting | Jinan | Shandong | +83 250001 | China |
|
| Affliated Hospital of Shandong Academy of Medical Sciences | Recruiting | Jinan | Shandong | +86 250001 | China |
|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | +86 250001 | China |
|
| Affliated Hospital of Jining Medical University | Recruiting | Jining | Shandong | +86 272000 | China |
|
| Liaocheng Cancer Hospital | Recruiting | Liaocheng | Shandong | +86 252000 | China |
|
| The People's Hospital of Pingyi Country | Recruiting | Linyi | Shandong | +86 276000 | China |
|
| Affliated Hospital of Taishan Medical University | Recruiting | Taian | Shandong | +86 271000 | China |
|
| The People's Liberation Army 88 Hospital | Recruiting | Taian | Shandong | +86 271000 | China |
|
| Weifang People's Hospital | Recruiting | Weifang | Shandong | +86 262000 | China |
|
| Yantai Yuhuangding Hospital | Recruiting | Yantai | Shandong | +86 264000 | China |
|
| Tengzhou center of people's hospital | Recruiting | Zaozhuang | Shandong | +86 277000 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |