Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455843
• Other study ID #: ShandongPH Jinan
• Status: Recruiting
• Phase: Phase 3
• First received: May 16, 2015
• Last updated: September 18, 2017
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: Shandong Provincial Hospital
• Contact: Xin Ye, M.D
• Phone: +86 0531-68773172
• Email: yexintaian2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be randomized to treated with microwave ablation and chemotherapy or treated with chemotherapy alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Other:
• Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Dezhou People's Hospital	Dezhou	Shandong
China	The Second People's Hospital of Dezhou	Dezhou	Shandong
China	Affliated Hospital of Shandong Academy of Medical Sciences	Jinan	Shandong
China	Jinan Military General Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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