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临床试验/NCT04764149
NCT04764149Unknown不适用

Efficacy and Safety of Platinum Plus Continuous Intravenous Infused 5-Fluorouracil With Low Dose and Long Term Versus Other Platinum-Based Chemotherapy in Recurrent Nasopharyngeal Carcinoma: A Case-Cohort Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 801 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
801
试验地点
1
主要终点
5-year overall survival

研究概览

简要总结

Local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. Systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.

详细描述

Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation, but failure in local control was observed in approximately 15% of patients.

Chemotherapy is the cornerstone of the treatment of recurrent NPC. Many studies were aimed at the systemic treatment of recurrent NPC, but most of them were retrospective studies or phase II trials with small samples. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for recurrent NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge.

Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in recurrent NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum containing chemotherapy with low-dose continuous infused 5-fluorouracil in recurrent NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.

排除标准

  • Age <18 or >70 years old
  • Pathologic type unknown or except type I-III of World Health Organization classification
  • Never underwent platinum-based chemotherapy
  • Lack of information about T classification and N classification when metastasis
  • Lost follow-up within one month from the start of treatment for metastasis
  • With other malignances

结局指标

主要结局

5-year overall survival

时间窗: 5 years after diagnosis of recurrent

The period until death is detected.

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yun-fei Xia

Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Sun Yat-sen University

研究点 (1)

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