Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
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 curative effect
研究概览
简要总结
- Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.
- Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.
3）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
- None
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
- 否
入选标准
- •initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- •KPS≥70 points.
- •the age of 18-70 years old, male or female.
- •no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / 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 upper limit of normal).
- •understand this study and signed informed consent.
排除标准
- •distant metastasis.
- •who had received prior chemotherapy.
- •patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- •pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
- •serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
研究组 & 干预措施
Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: Routine intravenous drip (Device)
Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: induction Routine-chemotherapy (Drug)
Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: induction Chrono-chemotherapy (Drug)
Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: cisplatin chrono-chemotherapy (Drug)
Melodie group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: cisplatin routine-chemotherapy (Drug)
Routine-Chemotherapy
Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Number of Participants with curative effect
时间窗: 1 year
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 5 years
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.
次要结局
- Progression-free survival(5 years)
- Overall survival(5 years)
研究者
Feng Jing
Chief physician/Professor
Guiyang Medical University