Efficacy and safety of Pemetrexed plus cisplatin as combinatioin chemotherapy for post-operative adenocarcinoma. ; Multi-center, single arm, open-label, phase II trial.

Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 106 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•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.

•- 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

发起方

Chonnam National University Hospital Hwasun Hospital