Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2

Study Overview
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Brief Summary
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The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.

Conditions
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Lung Adenocarcinoma Patients With Postoperative in pN2

Intervention / Treatment
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* Radiation: intensity-modulated radiation
* Radiation: intensity-modulated radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Lung adenocarcinoma Postoperative staging pN2 period Voluntary participation and informed consent Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy performance status( PS) score 0-2. Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L. Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) <upper limit of normal (ULN) of 1.5 times, bilirubin <1.5 × ULN. Renal function: serum creatinine <1.5 × ULN. Compliance, and can be regular follow-up, voluntary compliance with study requirements 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: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progression-free survival&Concurrent chemoradiotherapy<br>The first day of radiotherapy given pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, two cycles of chemotherapy given during radiotherapy; then continue to give two cycles of consolidation chemotherapy, 21 days as a cycle. Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. | Radiation: intensity-modulated radiation<br>* For concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks.<br>|
| Active Comparator: Progression-free survival&sequential chemoradiotherapy<br>Patients received adjuvant chemotherapy for four cycles,pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, 21 days as a cycle.Then accept the Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W. | Radiation: intensity-modulated radiation<br>* For sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | 01/01/2014-06/01/2016 | two and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 01/01/2014-01/01-2016 | two and a half years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival