Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 主要终点
- progress free survival
研究概览
简要总结
The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
详细描述
S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histological or cytological documented
- •NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.
- •Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
- •Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function.
- •At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy.
- •No any other following malignancy or any serious complication caused by metastatic encephaloma.
- •No any gastrointestinal diseases that could reduce the drug absorption.
- •Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included.
- •Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy.
排除标准
- •Any unstable systemic disease
- •Patients with exposure to any recent anticancer therapy outside of this trial.
- •Pregnant or breast-feeding women
研究组 & 干预措施
S-1 Group
Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)
干预措施: S-1 therapy (Drug)
Pemetrexed Group
Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed
干预措施: Pemetrexed therapy (Drug)
结局指标
主要结局
progress free survival
时间窗: 1 year
From date of randomization until the date of first documented progression.
次要结局
- overall survival(3 mouths, 6 mouths, 9 mouths, 1 year)
- objective response rate(3 mouths, 6 mouths, 9 mouths, 1 year)
- duration of response(6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year)