Stage I NSCLCPhase 3NCT02896166
Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
A Phase 3 study testing microwave ablation in people with Stage I NSCLC, run by Shandong Provincial Hospital at 2 sites in China.
Trial summary
Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I NSCLC
- What is being tested?
- microwave ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2016to Sep 2019
- 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
- Patient has a histologically or cytologically verified NSCLC,
- The tumors small enough to treat (usually <4 cm), and without chest pleura invasion.
- Clinical stage I NSCLC with no other sites of disease,.
- Patient is not a candidate for surgical removal of the cancer, or refused surgery.
- Patient is not a candidate for radiation therapy, or refused radiation therapy.
- Patient has > 6 month life expectancy.
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- Eastern Cooperative Oncology Group performance status of 0 to 2.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- Sufficient organ functions.
- Written informed consent.
Who cannot join
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- Uncontrollable diabetes mellitus.
- History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shandong Provincial Hospital
Jinan, Shandong, +86 250001
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, +86053168773172
About this study
Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. For those patients, microwave ablation (MWA) could be an alternative treatment. Several small sample retrospective studies verified that MWA could be an efficacy and safe treatment.
Read the detailed description
Patients with stage I non small cell lung cancer unfit for or refused surgery will be treated with MWA in the primary tumor sites.
- Conditions
- Stage I NSCLC
- Being tested
- microwave ablation
- Keywords
- nsclc and stage I and microwave ablation
- 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
eligible patients will be treated with microwave ablation in the primary tumor sites
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation | Experimental | The procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the microwave ablation antenna is confirmed by CT imaging. Receives: Other: microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From the date of randomization until the date of death from any cause，assessed up to 36 months
Secondary outcomes (1)
Disease free survival
Measured: From the date of randomization until the date of first documented progression，assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I NSCLCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xin Ye, Shandong Provincial Hospital
- Investigators
- Xin Ye, M.D., Principal investigator, Shandong Provincial Hospital affliated to Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896166
- Sponsor's protocol ID
- Shandong Provincial Hospital
- Status last verified
- Jun 2017
- First submitted
- 20 Aug 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02896166
- Acronym / sponsor ID
- Shandong Provincial Hospital
- Conditions
- Stage I NSCLC
- Keywords
- nsclc and stage I and microwave ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Sep 2016 (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.
Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. For those patients, microwave ablation (MWA) could be an alternative treatment. Several small sample retrospective studies verified that MWA could be an efficacy and safe treatment.
Detailed description
Patients with stage I non small cell lung cancer unfit for or refused surgery will be treated with MWA in the primary tumor sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microwave ablation | Experimental | Other: microwave ablationThe procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the microwave ablation antenna is confirmed by CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient has a histologically or cytologically verified NSCLC,
- The tumors small enough to treat (usually <4 cm), and without chest pleura invasion.
- Clinical stage I NSCLC with no other sites of disease,.
- Patient is not a candidate for surgical removal of the cancer, or refused surgery.
- Patient is not a candidate for radiation therapy, or refused radiation therapy.
Key exclusion criteria (6 listed)
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- Uncontrollable diabetes mellitus.
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 ablationeligible patients will be treated with microwave ablation in the primary tumor sites | Other | microwave ablation |
Primary outcome
Overall survival
Time frame: From the date of randomization until the date of death from any cause，assessed up to 36 months
1 secondary outcome
Disease free survival
Time frame: From the date of randomization until the date of first documented progression，assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Xin Ye, M.D. principal investigator
Shandong Provincial Hospital affliated to Shandong University
2 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 Stage I NSCLC, run by Shandong Provincial Hospital at 2 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 10 inclusion and 6 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 (+8615168887755, yexintaian2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date of randomization until the date of death from any cause，assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.