Clinical trial NCT02896166: Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
Official title: Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stage I NSCLC
Keywords: nsclc and stage I and microwave ablation
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patient has a histologically or cytologically verified NSCLC,
2. The tumors small enough to treat (usually \<4 cm), and without chest pleura invasion.
3. Clinical stage I NSCLC with no other sites of disease,.
4. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
5. Patient is not a candidate for radiation therapy, or refused radiation therapy.
6. Patient has \> 6 month life expectancy.
7. Eastern Cooperative Oncology Group performance status of 0 to 2.
8. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
9. Sufficient organ functions.
10. Written informed consent.

Exclusion Criteria:

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Uncontrollable diabetes mellitus.
6. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Primary outcomes:
measure: Overall survival
timeFrame: From the date of randomization until the date of death from any cause，assessed up to 36 months
Secondary outcomes:
measure: Disease free survival
timeFrame: From the date of randomization until the date of first documented progression，assessed up to 36 months
Other outcomes:
measure: 1-,2-, and 3-year survival rate
timeFrame: From the time of randomization to the end of 1-,2-, and 3-year,respectively
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital affliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital affliated to Shandong University
name: Xin Ye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: