Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
NCT ID: NCT03351842
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
460 participants
INTERVENTIONAL
2017-09-01
2024-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Undergo surgery, followed by observation. Patients receive no further therapy
Undergo surgery
Therapeutic conventional surgery, R0 resection
Arm II
Undergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses.
cis Platinum/Carboplatin, Pemetrexed Disodium
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Undergo surgery
Therapeutic conventional surgery, R0 resection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cis Platinum/Carboplatin, Pemetrexed Disodium
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Undergo surgery
Therapeutic conventional surgery, R0 resection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
* Patients must be randomized within 4 weeks from the date of surgery
* No prior chemotherapy or radiation for non-small cell lung cancer
* Performance status of 0 or 1
* Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
* Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease free for five years
* Granulocytes \>= 1,800/ul
* Platelets \>= 100,000/ul
* Bilirubin \< 1.5 mg/dl
* SGOT(serum glutamic-oxaloacetic transaminase) (AST) \< 2.0 x ULN(upper limit of normal value)
* There is evidence of distant metastases
* Suffered from other malignancies in five years
* Within the past January subjects received other drug trials
* Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
* Severe lung or heart disease, a history
* Refuses or is unable to sign informed consent to participate in trials
* The abuse of drugs or alcohol addicts.
* Patients with difficult to control bacterial, viral, fungal infections
* Having a personality or mental disorders, without civil capacity or restricted civil capacity.
* Being pregnant or lactating women.
19 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gening Jiang
Head of thoracic surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Thoracic Surgery Department of Shanghai Pulmonary Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yingran Shen
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K17-151
Identifier Type: -
Identifier Source: org_study_id