Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 7
- 主要终点
- Disease free survival rate
研究概览
简要总结
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.
详细描述
Primary endpoint : 2 year disease free survival
Secondary endpoints:
Overall survival, Frequency and severity of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Pemebit plus Cisplatin
Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
干预措施: Pemebit (Drug)
Pemebit plus Cisplatin
Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease free survival rate
时间窗: 2 year
Disease free survival time is measured from the date of enrollment to date of tumor recurrence.
次要结局
- Overall survival(4 year)
- Adverse events(4 months)
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital