Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Local/regional control rate, Acute and late toxicities
研究概览
简要总结
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.
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
- •Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
- •According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
- •Age between 18-70
- •Karnofsky performance status ≥70
- •WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
- •Without radiotherapy or chemotherapy
- •Signed study-specific consent form prior to study entry
排除标准
- •Patients with distant metastasis
- •Pregnant or lactating women
- •The presence of uncontrolled life-threatening illness
- •Patients who received radiotherapy or chemotherapy previously
研究组 & 干预措施
A
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
干预措施: Late-course accelerated hyperfractionated IMRT (Radiation)
A
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
干预措施: Concomitant cisplatin chemotherapy (Drug)
B
Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
干预措施: Concomitant cisplatin chemotherapy (Drug)
B
Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
干预措施: Conventionally fractionated IMRT (Radiation)
结局指标
主要结局
Local/regional control rate, Acute and late toxicities
时间窗: 2-Yr
次要结局
- Overall survival rate(5-Yr)
研究者
Heming Lu
Associate Professor
People's Hospital of Guangxi