Sequential Chemoradiotherapy With Reduced Target Delineation and Radiation Doses During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced nasopharyngeal carcinoma
详细描述
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. Besides, a common problem in locally advanced NPC is the narrow gap between the tumor and critical normal structures, which makes dose optimization difficult. Considering that significant tumor shrinkage may occur during induction chemotherapy, and incidences of distant metastases may be reduced by adjuvant chemotherapy, this study was designed to explore the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced NPC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
- •Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
- •KPS more than 70
- •Life expectancy of more than 6 months
- •Signed written informed consent
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 109/l Platelets count >= 100 * 109/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN
排除标准
- •Evidence of distant metastasis
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
结局指标
主要结局
Progression-free survival
时间窗: up to 5 years
The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years.
次要结局
- Changes of tumor volume(2 weeks after completion of induction chemotherapy)
- Distant metastasis-free survival(up to 5 years)
- Regional recurrence-free survival(up to 5 years)
- Local recurrence-free survival(up to 5 years)
- Locoregional failure patterns(up to 5 years)
- Number of participants with acute toxicities(during treatment)
- Relationship between treatment failure and dose received by target(up to 5 years)
- Overall survival(up to 5 years)
- Number of participants with late toxicities(up to 5 years)
研究者
Xiayun He, MD
Professor
Fudan University