A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Acute toxicities
研究概览
简要总结
The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.
详细描述
Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results.
Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation.
Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.
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
- •pathological confirmed squamous cell carcinoma, WHO II-III type,
- •clinical stage II (UICC 7th edition, 2009)
- •Karnovsky performance score > 70
- •first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer.
- •anticipated life span more than 6 month
- •Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
- •liver and renal function under the 1.25 normal upper limit
- •with written consent information
排除标准
- •have other cancer history
- •have chemotherapy history
- •have radiotherapy history
- •have head and neck surgery history(exclusion lymph node biopsy)
- •evidence showed distant metastasis or other cancer
- •other severe medical comorbidity
研究组 & 干预措施
Arm2-concurrent chemoradiotherapy group
Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks.
干预措施: cisplatin (Drug)
结局指标
主要结局
Acute toxicities
时间窗: 2 years
Acute toxicity will be measured by CTCAE3.0
次要结局
- Long term treatment results(5 years)
研究者
Jun-Lin Yi, MD
Professor
Chinese Academy of Medical Sciences