A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Local control rate
研究概览
简要总结
This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.
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 —（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，wight loss<30% during the latest 6 months.
- •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
- •No heart diseases that need cardiac glycoside
- •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.
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
- •Drug addiction,Alcoholism or AIDS.
研究组 & 干预措施
Huachansu Arm
Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.
干预措施: Huachansu (Drug)
Huachansu Arm
Patients in this arm will receive a treatment of Huachansu combined with thoracic radiotherapy.
干预措施: thoracic radiation (Radiation)
Control Arm
Patients in this arm will receive thoracic radiotherapy alone.
干预措施: thoracic radiation (Radiation)
结局指标
主要结局
Local control rate
时间窗: the date of randomization until progression inside the irradiation field, up to 3 years.
The outcome measure will be assessed by every 3-month follow-up examinations.
次要结局
- overall survival(the date of randomization until the death or the last follow up of the patients, up to 3 years.)
- progress-free survival(the date of randomization until progression or death from any cause, up to 3 years)
研究者
Kuai Le Zhao, MD
Professor
Fudan University