Clinical trial NCT02455843: Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
Official title: A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: microwave ablation
chemotherapy
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2015-05-28
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: progression free survival
timeFrame: up to 12 months after the last patient randomized
Secondary outcomes:
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Dezhou
country: China
facility: Dezhou People's Hospital
state: Shandong
city: Dezhou
country: China
facility: The Second People's Hospital of Dezhou
state: Shandong
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Jinan
country: China
facility: Affliated Hospital of Shandong Academy of Medical Sciences
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jining
country: China
facility: Affliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: The People's Hospital of Pingyi Country
state: Shandong
city: Taian
country: China
facility: Affliated Hospital of Taishan Medical University
state: Shandong
city: Taian
country: China
facility: The People's Liberation Army 88 Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Tengzhou center of people's hospital
state: Shandong
Study officials:
affiliation: Tengzhou Center of People's Hospital
name: Kai x Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Military General Hospital
name: Jing w Bi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.