Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Lung adenocarcinoma
- •Postoperative staging pN2 period
- •Voluntary participation and informed consent
- •Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
- •performance status( PS) score 0-
- •Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
- •Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) <upper limit of normal (ULN) of 1.5 times, bilirubin <1.5 × ULN.
- •Renal function: serum creatinine <1.5 × ULN.
- •Compliance, and can be regular follow-up, voluntary compliance with study requirements
排除标准
- •Do not meet the inclusion criteria
- •There is evidence of distant metastases
- •Suffered from other malignancies in five years
- •Within the past January subjects received other drug trials
- •Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
- •Severe lung or heart disease, a history
- •Refuses or is unable to sign informed consent to participate in trials
- •The abuse of drugs or alcohol addicts.
- •Patients with difficult to control bacterial, viral, fungal infections
- •Having a personality or mental disorders, without civil capacity or restricted civil capacity.
- •Being pregnant or lactating women.
研究组 & 干预措施
Progression-free survival&Concurrent chemoradiotherapy
The first day of radiotherapy given pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, two cycles of chemotherapy given during radiotherapy; then continue to give two cycles of consolidation chemotherapy, 21 days as a cycle.
Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W.
干预措施: intensity-modulated radiation (Radiation)
Progression-free survival&sequential chemoradiotherapy
Patients received adjuvant chemotherapy for four cycles,pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, 21 days as a cycle.Then accept the Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W.
干预措施: intensity-modulated radiation (Radiation)
结局指标
主要结局
progression-free survival
时间窗: two and a half years
01/01/2014-06/01/2016
次要结局
- Overall survival(two and a half years)
研究者
Hui Lin
The president of the People's Hospital of Guangxi
People's Hospital of Guangxi