Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
1 other identifier
interventional
275
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2015
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 16, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedSeptember 19, 2017
September 1, 2017
3 years
May 16, 2015
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Microwave plus chemotherapy
EXPERIMENTALIn 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 COMPARATORIn 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 ）
Interventions
Patients assigned to the combination group will be treated with microwave in the primary tumor site
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600, China
Dezhou People's Hospital
Dezhou, Shandong, +86 253000, China
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000, China
Jinan Military General Hospital
Jinan, Shandong, +83 250001, China
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001, China
Shandong Provincial Hospital
Jinan, Shandong, +86 250001, China
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000, China
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000, China
The People's Hospital of Pingyi Country
Linyi, Shandong, +86 276000, China
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000, China
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000, China
Weifang People's Hospital
Weifang, Shandong, +86 262000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000, China
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000, China
Related Publications (1)
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.
PMID: 25572816RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai x Zhang, M.D
Tengzhou Center of People's Hospital
- PRINCIPAL INVESTIGATOR
Jing w Bi, M.D.
Jinan Military General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of Chinese Anti-Cancer Association Professional Committee of lung cancer minimally invasive therapy combined therapy branch
Study Record Dates
First Submitted
May 16, 2015
First Posted
May 28, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
September 19, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share