Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC

September 18, 2017 updated by: Xin Ye, Shandong Provincial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

275

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Binzhou, Shandong, China, +86 256600
        • Recruiting
        • Binzhou Medical University Hospital
        • Contact:
      • Dezhou, Shandong, China, +86 253000
        • Recruiting
        • Dezhou People's Hospital
        • Contact:
      • Dezhou, Shandong, China, +86 253000
        • Recruiting
        • The Second People's Hospital of Dezhou
        • Contact:
      • Jinan, Shandong, China, +83 250001
        • Recruiting
        • Jinan Military General Hospital
        • Contact:
      • Jinan, Shandong, China, +86 250001
        • Recruiting
        • Affliated Hospital of Shandong Academy of Medical Sciences
        • Contact:
      • Jinan, Shandong, China, +86 250001
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Jining, Shandong, China, +86 272000
        • Recruiting
        • Affliated Hospital of Jining Medical University
        • Contact:
      • Liaocheng, Shandong, China, +86 252000
        • Recruiting
        • Liaocheng Cancer Hospital
        • Contact:
      • Linyi, Shandong, China, +86 276000
        • Recruiting
        • The People's Hospital of Pingyi Country
        • Contact:
      • Taian, Shandong, China, +86 271000
        • Recruiting
        • Affliated Hospital of Taishan Medical University
        • Contact:
      • Taian, Shandong, China, +86 271000
        • Recruiting
        • The People's Liberation Army 88 Hospital
        • Contact:
      • Weifang, Shandong, China, +86 262000
        • Recruiting
        • Weifang People's Hospital
        • Contact:
          • Guo hua Yu, M.D
          • Phone Number: +86 13685368817
          • Email: ghyry@126.com
      • Yantai, Shandong, China, +86 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Zaozhuang, Shandong, China, +86 277000
        • Recruiting
        • Tengzhou center of people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 ）
Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site
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 ）
Other: Microwave ablation
Patients assigned to the combination group will be treated with microwave in the primary tumor site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 months after the last patient randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Principal Investigator: Kai x Zhang, M.D, Tengzhou center of people's hospital
  • Principal Investigator: Jing w Bi, M.D., Jinan Military General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 16, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShandongPH Jinan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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