Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

Study Overview
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Brief Summary
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Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.

Detailed Description
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The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring. 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.

Official Title
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A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%

Conditions
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Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment, Histological Type of Neoplasm

Intervention / Treatment
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* Drug: cis Platinum/Carboplatin, Pemetrexed Disodium
* Procedure: Undergo surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely resected Stage I NSCLC as defined by the International Staging System 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) Exclusion Criteria: Do not meet the inclusion criteria 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I<br>Undergo surgery, followed by observation. Patients receive no further therapy | Procedure: Undergo surgery<br>* Therapeutic conventional surgery, R0 resection<br>|
| Experimental: Arm II<br>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. | Drug: cis Platinum/Carboplatin, Pemetrexed Disodium<br>* Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours<br>* Other names: Paraplatin;Procedure: Undergo surgery<br>* Therapeutic conventional surgery, R0 resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free-Survival-Rate | the percentage of people in the trial who are alive and cancer free after a specified number of years | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall-Survival-Rate | the percentage of people in the trial who alive, with or without signs of cancer | up to 60 months | 
| Disease-Free-Survival-Time | From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first | up to 60 months | 
| Overall-Survival-Time | Time from randomization until death from any cause | up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer