Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety
研究概览
简要总结
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
- •Karnofsky score≥70;
- •Age 18-70 years old, male or female;
- •No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
- •To understand this study and sign informed consent form.
排除标准
- •A distant metastasis;
- •Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
- •Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
- •Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
研究组 & 干预措施
Melodie group
Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: induction chemotherapy (Drug)
Melodie group
Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: cisplatin chrono-chemotherapy (Drug)
Melodie group
Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
Routine-chemotherapy group
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: Routine intravenous drip (Device)
Routine-chemotherapy group
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: induction chemotherapy (Drug)
Routine-chemotherapy group
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
Routine-chemotherapy group
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: cisplatin routine-chemotherapy (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 5 year
次要结局
- Number of Participants with curative effect(1 year)
研究者
Feng Jing
Guiyang Medical College
Guiyang Medical University