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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
Sponsor:
Information provided by (Responsible Party):
Xin Ye, Shandong Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Other: Microwave ablation Phase 3

Detailed Description:
Patients will be randomized to treated with microwave ablation and chemotherapy or treated with chemotherapy alone.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 ）
 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 ）
 Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of advanced stage NSCLC (stage IIIB or IV) which is confirmed by histology or cytology methods.
  2. Measurable disease other than the primary tumors site according to RECIST1.1.
  3. Eastern Cooperative Oncology Group (ECOG) score of 0-2

  4. Adequate organ function, defined as all of the following:

    1. Left ventricular ejection fraction >50% or within institution normal values.
    2. Absolute neutrophil count (ANC)>1500/mm3.
    3. Platelet count >75,000/mm3
    4. Estimated creatinine clearance>45m1/min.
    5. Total bilirubin<1.5 times institutional ULN (Patients with Gilbert's Syndrome total bilirubin must be <4 times institutional ULN).
    6. 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).
  5. Age ≥ 18 years.
  6. Written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice（GCP） guidelines.

Exclusion Criteria:

  1. Previous anti-cancer treatments including chemotherapy, radiation therapy or targeted therapy..
  2. Active symptomatic brain metastases. Dexamethasone therapy will be allowed if administered as a stable dose for at least 4 weeks before randomization.
  3. Any other current malignancy or malignancy diagnosed within the past five (5) years.
  4. 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.
  5. 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.
  6. 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.
  7. Female patients of childbearing potential who are nursing or are pregnant.
  8. Patients unable to comply with the protocol in the opinion of the investigator.
  9. 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.
  10. Known or suspected active drug or alcohol abuse in the opinion of the investigator.
  11. Major surgery within 4 weeks of starting study treatment. Use of any investigational drug within 4 weeks of randomisation
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xin Ye, M.D +86 0531-68773172 yexintaian2014@163.com
Contact: Zhi g Wei, M.D +86 0531-68773171 weizhigang321321@163.com

Locations
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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   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Principal Investigator: Kai x Zhang, M.D Tengzhou Center of People's Hospital
Principal Investigator: Jing w Bi, M.D. Jinan Military General Hospital
More Information
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Publications of Results:

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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
Keywords provided by Xin Ye, Shandong Provincial Hospital:
microwave ablation
chemotherapy
Additional relevant MeSH terms:
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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