Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
详细描述
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage IVA and IVB nasopharyngeal carcinoma
- •at lease one measurable lesion
- •receive no chemotherapy or radiotherapy before
- •Eastern CooperativeOncology Group performance status of 0 to
- •Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
排除标准
- •mismatch the inclusion criteria
- •previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
- •allergy to any of these three drugs
研究组 & 干预措施
treatment arm
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
干预措施: Docetaxel (Drug)
treatment arm
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
干预措施: Cisplatin (Drug)
treatment arm
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
干预措施: Capecitabine (Drug)
结局指标
主要结局
overall response rate
时间窗: every 4 weeks,up to completion of treatment(approximately 6 months)
overall response rate is the sum of complete response rate and partial response rate.
次要结局
- complete response rate(every 4 weeks,up to completion of treatment(approximately 6 months))
- 1 year overall survival rate(date from diagnosis of NPC to death of any cause (up to 12 months))
- 1 year progression free survival rate(date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.)
- safety profiles (including hematologic toxicities and non-hematologic toxicities.)(date from diagnosis of NPC to completion of study (about 6 months))
研究者
Liang Wang
Doctor
Sun Yat-sen University