A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 2
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.
详细描述
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven squamous cell carcinoma of esophagus .
- •Locally advanced esophageal cancer , with no operation indication
- •M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
- •Subjects haven't been given neither radiotherapy nor chemotherapy before
- •Age of 18-70
- •Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
- •With no difficulty in eating
- •Expected lifetime ≧3 months
排除标准
- •Invasion to surrounding organ ( T4 disease ) .
- •Distant metastasis , except M1a disease .
- •Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- •Women in status of pregnancy
- •Patients who have complications exist as following:
- •Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
- •A history of myocardial infarction in the past 6 months
- •There is a need for antibiotic treatment of acute bacterial or fungal infection
- •Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
- •Drug addiction, alcoholism and AIDS disease or long-term virus carriers
- •Uncontrollable seizures, or loss of insight because of mental illness
研究组 & 干预措施
Paclitaxel plus Cisplatin with radiotherapy
patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
干预措施: Paclitaxel plus Cisplatin with radiotherapy (Other)
S1 plus Cisplatin with radiotherapy
patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin
干预措施: S1 plus Cisplatin with radiotherapy (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: five years after enrollment
次要结局
- Progression-free survival (PFS)(five years after enrollment)
研究者
Feng Gao
Principal Investigator
Mianyang Central Hospital