None listed
Conditions
Interventions
Drug : Pemetrexed (500 mg/m2), Cisplatin (75 mg/m2)
Intravenous infusion
3 week interval, 4 cycles
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or Female older than 19 years old - Adenocarcinoma of Lung - Stage IB~IIIA according to TNM classification (version 7) - Completely resected lung cancer (RO resection) * Definition of R0 resection 1) N1-2: R/O resection with lobectomy & mediastinal LN dissection(MLND) 2) N0: R/O resection with lobectomy with or without MLND - First dose of Adjuvant chemotherapy should be within 4 to 8 weeks after surgery. - Weight loss =10% within 3 months - Adequate organ function Absolute Neutrophil Count >1.500/mm³, Platelet>100,000/mm³, WBC>3,000/ mm³,Hemoglobin>9g/dL Bilirubin=1.5×ULN, AST/ALT<2.5×ULN Creatinine clearance=30mL/min, Serum creatinine=1.5mg/dL - Subjects who did not received cytotoxic chemotherapy or hormone therapy for lung cancer - ECOG performance status 0-1 - Able to understand and willing to comply with scheduled visits, treatment plan and tests - Women of child-bearing potential must have negative pregnancy test within 21 days of treatment and comply with highly effective contraception methods.
Exclusion criteria
Exclusion criteria: - Presence or history of malignant disease within the past 5 years. - Subjects who received neoadjuvant chemotherapy before surgery. - Subjects who require PORT, postoperative radiation therapy. - Subjects with metastatic disease except regional lymph nodes. - Severe infection requiring antibiotic treatment within 2 weeks. - HIV positive cases - Subjects with severe impairment of cardiopulmonary function - Female subjects in breast feeding female or intent to child bearing during treatment - History of autoimmune diseases or being treated with immune suppressive drugs - Subjects with symptomatic Neuropathy > CTC grade 1 - Other severe disease or medical conditions (uncontrolled hypertension, diabetes mellitus, coronary artery disease, metabolic syndromes) - Subjects with difficulties to comply with scheduled visits - Subjects with severe bleeding diasthesis - Subjects enrolled to other clinical trials within 3 months of screening - Other uncontrolled medical conditions difined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Rate;Adverse events, frequency and severity;Performance status score;4 cycles completion rate | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Chul Kim
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed