NCT03210389Unknown2 期
A Prospective, Single-arm, and Open Clinical Trial of Chemotherapy With Lobaplatin and 5-FU on Efficacy and Safety in Recurrent Local or Distant Advanced NPC.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.
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
- •NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded.
- •Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1)
- •ECOG 0 or 1
- •Expected survival ≥ 1 year
- •Without dysfunction of heart, lung, liver, kidney and hematopoiesis
- •Patients are voluntary and signed informed consent
- •No other anti-tumor treatment (including steroid)
排除标准
- •Allergy history to platinum
- •Use of 5-FU in last 6 months
- •Had major surgery in last 4 weeks, or the wound has not completely healed
- •Toxicity from previous treatment is still ≥CTC AE grade 3
- •History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin
- •Dysfunction of heart
- •Bleeding ≥CTC AE grade 3
- •Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention
- •Patients participated in clinical trials of other drugs within last 4 weeks
- •Mental illness
研究组 & 干预措施
lobaplatin+5-FU
Experimental
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
干预措施: Lobaplatin (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 years after chemotherapy
the time from randomization to death or disease progression
次要结局
- overall survival(2 years after chemotherapy)
- objective response rate(2 years after chemotherapy)
研究者
Yun-fei Xia
Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor
Sun Yat-sen University
研究点 (1)
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