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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

Tracking Information
First Submitted Date  ICMJE May 16, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date September 19, 2017
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
progression free survival [ Time Frame: up to 12 months after the last patien randomized ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
Official Title  ICMJE A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site
Study Arms  ICMJE
  • 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 )
    Intervention: Other: Microwave ablation
  • 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 )
    Intervention: Other: Microwave ablation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
275
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
12
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455843
Other Study ID Numbers  ICMJE ShandongPH Jinan
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xin Ye, Shandong Provincial Hospital
Study Sponsor  ICMJE Shandong Provincial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kai x Zhang, M.D Tengzhou Center of People's Hospital
Principal Investigator: Jing w Bi, M.D. Jinan Military General Hospital
PRS Account Shandong Provincial Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP