Non Small Cell Lung CancerPhase 3NCT02455843
Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
A Phase 3 study testing Microwave ablation in people with Non Small Cell Lung Cancer, run by Shandong Provincial Hospital at 14 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Microwave ablation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 14 sitesChina
- Study dates
- May 2015to May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600
Shao shui Chen, M.D, +86 15169959936, byfychenss@126.com
- Recruiting
Dezhou People's Hospital
Dezhou, Shandong, +86 253000
Yu ting Dong, +86 13969286066, dyt1963@163.com
- Recruiting
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000
Chun tang Wang, M.D, +86 13181378288, dzeyxwct@sina.com
- Recruiting
Jinan Military General Hospital
Jinan, Shandong, +83 250001
Jing wang Bi, M.D, +86 15963119538, jingwangbi@outlook.com
- Recruiting
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001
Ya hong Sun, M.D, 13606415915, sunyahong0915@163.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, +86 250001
Xin Ye, M.D, +86 0531-68773171, yexintaian2014@163.com
- Recruiting
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000
Jun ye Wang, M.D, +86 13563771996, jiningwangjunye@163.com
- Recruiting
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000
Qing liang Feng, M.D, +86 15339949567, fql-123@sohu.com
- Recruiting
The People's Hospital of Pingyi Country
Linyi, Shandong, +86 276000
Xing lu Xu, M.D, +86 18265398816, xlk2082@126.com
- Recruiting
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000
Ben hua Zhang, M.D, +86 15169887577, zhangbenhua1964@163.com
- Recruiting
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000
Li cheng Zhang, M.D, +86 13605383651, zhanglc88@aliyun.com
- Recruiting
Weifang People's Hospital
Weifang, Shandong, +86 262000
Guo hua Yu, M.D, +86 13685368817, ghyry@126.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000
Liang ming Zhang, M.D, +86 18660079893, zhanglmdr@163.com
- Recruiting
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000
Kai xian Zhang, M.D, +86 18663069829, kaixianzhang@aliyun.com
About this study
Official title: 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.
Read the detailed description
Patients will be randomized to treated with microwave ablation and chemotherapy or treated with chemotherapy alone.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Microwave ablation
- Keywords
- microwave ablation, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationOther
Patients assigned to the combination group will be treated with microwave in the primary tumor site
| Study group | Role | What they receive |
|---|---|---|
| Microwave plus chemotherapy | Experimental | 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 ） Receives: Other: Microwave ablation |
| chemotherapy | Placebo comparator | 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 ） Receives: Other: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
From the start of chemotherapy or ablation to the date of progression or death
Measured: up to 12 months after the last patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xin Ye, Shandong Provincial Hospital
- Investigators
- Kai x Zhang, M.D, Principal investigator, Tengzhou Center of People's HospitalJing w Bi, M.D., Principal investigator, Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455843
- Sponsor's protocol ID
- ShandongPH Jinan
- Status last verified
- Sep 2017
- First submitted
- 16 May 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25572816
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Phase III Trial of Microwave Plus Chemotherapy Versus Chemotherapy for Advanced NSCLC
- ClinicalTrials.gov ID
- NCT02455843
- Acronym / sponsor ID
- ShandongPH Jinan
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- microwave ablation, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microwave plus chemotherapy | Experimental | Other: Microwave ablationIn 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 comparator | Other: Microwave ablationIn 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 ） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Age ≥ 18 years.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationPatients assigned to the combination group will be treated with microwave in the primary tumor site | Other | Microwave plus chemotherapy, chemotherapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Results publication: PubMed 25572816Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai x Zhang, M.D principal investigator
Tengzhou Center of People's Hospital
Jing w Bi, M.D. principal investigator
Jinan Military General Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Microwave ablation in people with Non Small Cell Lung Cancer, run by Shandong Provincial Hospital at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Ye, M.D (+86 0531-68773172, yexintaian2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: up to 12 months after the last patient randomized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.