NCT01831531已完成2 期
Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joined the study voluntarily and signed informed consent form;
- •Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
- •Both genders
- •Esophageal squamous cell carcinoma confirmed by pathology
- •Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
- •No radiotherapy, chemotherapy or other treatments prior to enrollment
- •PS ECOG 0-2
- •Life expectancy of more than 3 months
- •Hemoglobin（Hb）≥9 g/dL
- •WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
- •platelet count (Pt) ≥100x 109/L
- •Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
- •Renal function: creatinine < 1.5 x ULN
- •No immuno-deficiency
- •Use of an effective contraceptive for adults to prevent pregnancy.
排除标准
- •Complete esophageal obstruction
- •Deep esophageal ulcer
- •Esophageal perforation
- •Haematemesis
- •After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- •Participation in other interventional clinical trials within 30 days
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Drug addiction
- •Alcoholism or AIDS
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- •Patient who has metastasis such as lung, liver metastasis
研究组 & 干预措施
S-1
Experimental
Patients will receive chemoradiation with S-1.
Interventions:
Drug: S-1 Radiation: Radiation therapy
干预措施: S-1 (Drug)
S-1
Experimental
Patients will receive chemoradiation with S-1.
Interventions:
Drug: S-1 Radiation: Radiation therapy
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Number of participants with adverse events
时间窗: 1 years
3-yr local control rate
时间窗: 3 years
次要结局
- Overall survival(3 years)
研究者
Kuai Le Zhao, MD
Professor of Radiation Oncology
Fudan University
研究点 (1)
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