Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
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ClinicalTrials.gov Identifier: NCT02455843 |
Recruitment Status : Unknown
Verified September 2017 by Xin Ye, Shandong Provincial Hospital.
Recruitment status was: Recruiting
First Posted : May 28, 2015
Last Update Posted : September 19, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Other: Microwave ablation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 275 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC |
Study Start Date : | May 2015 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | May 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Microwave plus chemotherapy
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 )
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Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site |
Placebo Comparator: chemotherapy
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 )
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Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site |
- progression free survival [ Time Frame: up to 12 months after the last patient randomized ]From the start of chemotherapy or ablation to the date of progression or death

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Adequate organ function, defined as all of the following:
- Left ventricular ejection fraction >50% or within institution normal values.
- Absolute neutrophil count (ANC)>1500/mm3.
- Platelet count >75,000/mm3
- Estimated creatinine clearance>45m1/min.
- Total bilirubin<1.5 times institutional ULN (Patients with Gilbert's Syndrome total bilirubin must be <4 times institutional ULN).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) < three times the institutional upper limit of normal (ULN) (if related to liver metastases<five times institutional ULN).
- Age ≥ 18 years.
- Written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice(GCP) guidelines.
Exclusion Criteria:
- Previous anti-cancer treatments including chemotherapy, radiation therapy or targeted therapy..
- Active symptomatic brain metastases. Dexamethasone therapy will be allowed if administered as a stable dose for at least 4 weeks before randomization.
- Any other current malignancy or malignancy diagnosed within the past five (5) years.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation.
- Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry.
- Female patients of childbearing potential who are nursing or are pregnant.
- Patients unable to comply with the protocol in the opinion of the investigator.
- Active hepatitis B infection (defined as presence of Hepatitis B DNA), active hepatitis C infection (defined as presence of Hepatitis C RNA) and/or known HIV carrier.
- Known or suspected active drug or alcohol abuse in the opinion of the investigator.
- Major surgery within 4 weeks of starting study treatment. Use of any investigational drug within 4 weeks of randomisation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455843
Contact: Xin Ye, M.D | +86 0531-68773172 | yexintaian2014@163.com | |
Contact: Zhi g Wei, M.D | +86 0531-68773171 | weizhigang321321@163.com |
China, Shandong | |
Binzhou Medical University Hospital | Recruiting |
Binzhou, Shandong, China, +86 256600 | |
Contact: Shao shui Chen, M.D +86 15169959936 byfychenss@126.com | |
Dezhou People's Hospital | Recruiting |
Dezhou, Shandong, China, +86 253000 | |
Contact: Yu ting Dong +86 13969286066 dyt1963@163.com | |
The Second People's Hospital of Dezhou | Recruiting |
Dezhou, Shandong, China, +86 253000 | |
Contact: Chun tang Wang, M.D +86 13181378288 dzeyxwct@sina.com | |
Jinan Military General Hospital | Recruiting |
Jinan, Shandong, China, +83 250001 | |
Contact: Jing wang Bi, M.D +86 15963119538 jingwangbi@outlook.com | |
Affliated Hospital of Shandong Academy of Medical Sciences | Recruiting |
Jinan, Shandong, China, +86 250001 | |
Contact: Ya hong Sun, M.D 13606415915 sunyahong0915@163.com | |
Shandong Provincial Hospital | Recruiting |
Jinan, Shandong, China, +86 250001 | |
Contact: Xin Ye, M.D +86 0531-68773171 yexintaian2014@163.com | |
Affliated Hospital of Jining Medical University | Recruiting |
Jining, Shandong, China, +86 272000 | |
Contact: Jun ye Wang, M.D +86 13563771996 jiningwangjunye@163.com | |
Liaocheng Cancer Hospital | Recruiting |
Liaocheng, Shandong, China, +86 252000 | |
Contact: Qing liang Feng, M.D +86 15339949567 fql-123@sohu.com | |
The People's Hospital of Pingyi Country | Recruiting |
Linyi, Shandong, China, +86 276000 | |
Contact: Xing lu Xu, M.D +86 18265398816 xlk2082@126.com | |
Affliated Hospital of Taishan Medical University | Recruiting |
Taian, Shandong, China, +86 271000 | |
Contact: Ben hua Zhang, M.D +86 15169887577 zhangbenhua1964@163.com | |
The People's Liberation Army 88 Hospital | Recruiting |
Taian, Shandong, China, +86 271000 | |
Contact: Li cheng Zhang, M.D +86 13605383651 zhanglc88@aliyun.com | |
Weifang People's Hospital | Recruiting |
Weifang, Shandong, China, +86 262000 | |
Contact: Guo hua Yu, M.D +86 13685368817 ghyry@126.com | |
Yantai Yuhuangding Hospital | Recruiting |
Yantai, Shandong, China, +86 264000 | |
Contact: Liang ming Zhang, M.D +86 18660079893 zhanglmdr@163.com | |
Tengzhou center of people's hospital | Recruiting |
Zaozhuang, Shandong, China, +86 277000 | |
Contact: Kai xian Zhang, M.D +86 18663069829 kaixianzhang@aliyun.com |
Principal Investigator: | Kai x Zhang, M.D | Tengzhou Center of People's Hospital | |
Principal Investigator: | Jing w Bi, M.D. | Jinan Military General Hospital |
Responsible Party: | Xin Ye, Chairman of Chinese Anti-Cancer Association Professional Committee of lung cancer minimally invasive therapy combined therapy branch, Shandong Provincial Hospital |
ClinicalTrials.gov Identifier: | NCT02455843 |
Other Study ID Numbers: |
ShandongPH Jinan |
First Posted: | May 28, 2015 Key Record Dates |
Last Update Posted: | September 19, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
microwave ablation chemotherapy |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |