The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- PFS (progression free survival)
研究概览
简要总结
To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.
详细描述
All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total dose and dose/fraction (Fr) as follows: PTV (planned target volume)_1:70 grays (Gy) at 2 Gy/ Fr, PTV_2:63 Gy at 1.8 Gy/ Fr, PTV_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All toxicities were gauged based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE 4.03).
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
- •Pathological confirmed nasopharyngeal carcinoma.
- •Staged as III to IVB.
- •18-75 years old.
- •Performance status ≤
- •No previous chemotherapy or radiotherapy.
- •No concurrent malignancies or a history of other malignancies.
- •Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L).
- •Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min).
- •Without serious co-morbidity.
排除标准
- •Stage I-II or IVC.
- •Allergic to cisplatin or capecitabine
- •Age <18 or >75
- •Performance Status >
- •Without adequate bone marrow or liver function or renal function.
- •Severe co-morbidity and can not tolerate chemotherapy.
- •Other conditions not suitable for the study on the discretion of charging doctor.
研究组 & 干预措施
experimental arm
Induction chemotherapy: capecitabine tablet 1000mg/m2 po bid from day1 to 14,cisplatin injection 80mg/m2 iv day1,every 3 weeks for a total of 3 cycles. Then followed by concurrent chemoradiotherapy with cisplatin injection 100mg/m2 iv every 3 weeks for a total of 2 cycles.
干预措施: cisplatin, capecitabine (Drug)
结局指标
主要结局
PFS (progression free survival)
时间窗: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
progression free survival
次要结局
未报告次要终点