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临床试验/NCT03403829
NCT03403829Unknown3 期

A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Fudan University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
360
试验地点
1
主要终点
Distant metastatic free survival

研究概览

简要总结

Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

详细描述

We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
  • Pathology: WHO II/II
  • No prior anti-tumor treatment
  • Age 18-60
  • Adequate blood supply
  • Informed consent obtained

排除标准

  • Pathology: WHO I
  • Combined with other malignant tumor

研究组 & 干预措施

maintenance arm

Experimental

Gemcitabine maintenance treatment

干预措施: Gemcitabine (Drug)

maintenance arm

Experimental

Gemcitabine maintenance treatment

干预措施: standard chemoradiotherapy (Radiation)

control arm

Sham Comparator

observe and follow-up

干预措施: standard chemoradiotherapy (Radiation)

结局指标

主要结局

Distant metastatic free survival

时间窗: 5 year

from enrollment to distant metastatis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chaosu Hu

Professor

Fudan University

研究点 (1)

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