Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

Study Overview
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Brief Summary
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Two-Year Disease Free Survival Rate of Stage IB IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.

Detailed Description
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Primary endpoint : 2 year disease free survival Secondary endpoints: Overall survival, Frequency and severity of adverse events

Official Title
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Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial

Conditions
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Adenocarcinoma, Lung Neoplasm

Intervention / Treatment
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* Drug: Pemebit
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adenocarcinoma of Lung Postoperative pathologic stage IB IIIA Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND Adjuvant treatment should start between 4 to 6 weeks after surgery ECOG performance status 0-1 Weight loss during last 3 months should be less than 10%. Normal hematologic, hepatic and renal function Neutrophil count > 1500 /microliter, Platelet > 100,000/microliter, Hemoglobin > 9 g/dL Bilirubin <=1.5 x upper limit normal, transaminase < 2.5 x upper limit normal Serum Creatinine <=1.5 mg/dL Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test. Exclusion Criteria: Other malignant neoplastic disease within 5 years. Neoadjuvant chemotherapy before surgery of lung cancer Patients who will be treated with postoperative radiation. Stage IIIB or IV lung cancer Severe infection, or cardiorespiratory, hematologic illness HIV positive cases Pregnancy or lactating women Autoimmune diseases or those who receiving immune suppressive treatment Symptomatic neuropathy > CTCAE grade 1 Those who consented other clinical trials within 3 months Other significant medical conditions contraindicated to clinical trial

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemebit plus Cisplatin<br>Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles | Drug: Pemebit<br>* 500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles<br>* Other names: Pemetrexed;Drug: Cisplatin<br>* 75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival rate | Disease free survival time is measured from the date of enrollment to date of tumor recurrence. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival time is measured from the date of enrollment to date of death from any cause. Participants who are alive when the data lock or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive. | 4 year | 
| Adverse events | adverse events using common terminology criteria for adverse events 4.0 | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery