NCT02913066Unknown2 期
Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
Mianyang Central Hospital2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Complete Remission Rate (CR)
研究概览
简要总结
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy.
Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
详细描述
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy;
control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.
Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
Primary Outcome Measure is complete remission rate.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology or cytology confirmed esophageal squamous cell carcinoma.
- •There are measurable lesions in the RECIST standard.
- •American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
- •Age younger than 75 years old.
- •Eastern Cooperative Oncology Group physical status score was 0 ~
- •No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.
- •Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.
- •Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L.
- •Cr≤1.25 upper normal limit or CCr≥60 mL/min.
- •Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.
- •A history of interstitial pneumonia and interstitial pneumonia.
- •FEV1>0.8 liters.
- •Patients or family members signed a formal informed consent.
排除标准
- •Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
- •Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
- •Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
- •Patients with distant metastases.
- •There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
- •Can't understand the test requirements, or patients may not comply with the requirements of the test.
- •There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.
- •An allergic reaction known to have 3 or 4 levels of any treatment.
- •Had participated in other clinical trials in the past 30 days.
- •The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.
结局指标
主要结局
Complete Remission Rate (CR)
时间窗: Three months after radiotherapy finished
Complete response rate of primary tumor which will be measured by endoscopy and computer tomography
次要结局
- Overall Survival (OS)(Two years after adjuvant chemotherapy finished)
- Progression-Free-Survival (PFS)(Two years after adjuvant chemotherapy finished)
研究者
Xiaobo Du
Principal Investigator
Mianyang Central Hospital
研究点 (2)
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