A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma
- •Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
- •Eastern Cooperative Oncology Group (ECOG) performance status 1-2
- •Estimated life expectancy of at least 12 weeks
- •Charlson comorbidity index≤4
- •Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
- •Adequate renal function: creatinine grade 0 or 1
- •Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
- •Weight loss≤15% during 6 months prior to diagnosis
- •Forced expiratory volume second≥1L
排除标准
- •Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
- •Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
- •Contraindication for chemotherapy or radiotherapy
- •Malignant pleural or pericardial effusion
- •Women in pregnancy or lactation period
- •Women who has the probability of pregnancy without contraception
- •Weight loss≥15% during 3 months prior to diagnosis
- •In other clinical trials within 30 days
- •Addicted in drugs or alcohol, AIDS patients
- •Uncontrollable seizure or psychotic patients without self-control ability
- •Severe allergy or idiosyncrasy
- •Not suitable for this study judged by researchers
研究组 & 干预措施
Docetaxel + Nedaplatin + Radiotherapy
Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation.
干预措施: Docetaxel (Drug)
Docetaxel + Nedaplatin + Radiotherapy
Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation.
干预措施: Nedaplatin (Drug)
Docetaxel + Nedaplatin + Radiotherapy
Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation.
干预措施: chest radiation (Radiation)
结局指标
主要结局
Maximum tolerated dose
时间窗: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Occurrence of dose limiting toxicity
时间窗: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
次要结局
- Occurrence and severity of adverse events(From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks))
- Dynamic plasma concentration of docetaxel and nedaplatin(From start of week 1 to the end of combination treatment (6.5 weeks))
- Clinical response rate(8 weeks after end of combination treatment)
研究者
Hui Liu
Prof.
Sun Yat-sen University