NCT00577057Unknown不适用
Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
Hospital Authority, Hong Kong6 个研究点 分布在 1 个国家目标入组 798 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 798
- 试验地点
- 6
- 主要终点
- Progression-free survival
研究概览
简要总结
The objectives of this clinical study are threefold:
- To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
- To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 nasopharyngeal carcinoma
- •Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
- •Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
- •Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
- •Liver scan if SGOT exceeds the institutional upper limit of normal
- •Adequate marrow: WBC > 4 and platelet > 100
- •Adequate renal function: creatinine clearance > 60 ml/min.
- •Satisfactory performance status: > 2 by ECOG System.
排除标准
- •WHO Type I squamous cell carcinoma or adenocarcinoma
- •Age > 70
- •Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
结局指标
主要结局
Progression-free survival
时间窗: 5-year
Overall Survival
时间窗: 5-year
次要结局
- Overall / Locoregional / Distant Failure Free Rate(5-year)
- Chemotherapy and RT toxicity(within 90 day from commencement of RT)
- Late Toxicity(5-year)
研究者
研究点 (6)
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