Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
NCT ID: NCT02455843
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
275 participants
INTERVENTIONAL
2015-05-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 ）
Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site
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 ）
Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site
Interventions
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Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Xin Ye
Chairman of Chinese Anti-Cancer Association Professional Committee of lung cancer minimally invasive therapy combined therapy branch
Principal Investigators
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Kai x Zhang, M.D
Role: PRINCIPAL_INVESTIGATOR
Tengzhou Center of People's Hospital
Jing w Bi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jinan Military General Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ShandongPH Jinan
Identifier Type: -
Identifier Source: org_study_id