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临床试验/NCT04472403
NCT04472403Unknown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 Metastatic 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 2,000 人开始时间: 2019年11月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
5-year overall survival

研究概览

简要总结

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Thus, 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. With the use of intensive chemoradiotherapy, excellent treatment outcomes can be achieved for local control, but disease failure was observed in approximately 20% of patients. Moreover, approximately 10% of newly diagnosed patients diagnosed with metastasis, resulting in about 30% of NPC patients will present with either synchronous or metachronous metastasis in total.

Chemotherapy is the cornerstone of the treatment of metastatic NPC. Many studies were aimed at the systemic treatment of metastatic NPC, but most of them were retrospective studies or phase II trials with small samples. The outcome of metastatic NPC is poor with a median OS of about 20 months. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for metastatic 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 metastatic 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 metastatic 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

  • Nasopharyngeal carcinoma diagnosed by pathology or cytology
  • Distant metastasis confirmed by Radiographic assessments or pathology.
  • Patients ever received systemic chemotherapy.

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
  • Without other malignances

结局指标

主要结局

5-year overall survival

时间窗: 5 years after diagnosis of metastasis

The period until death is detected.

5-year subsequent-line treatment-free survival

时间窗: 5 years after the start of the first-line treatment

The period until earliest of the start date of subsequent-line treatment or death is detected.

5-year survival without symptoms and toxicity

时间窗: 5 years after diagnosis of metastasis

The period until any events (death or disease progression or ≥grade 3 chemotherapy-related haematological toxicity) is detected.

次要结局

  • Haematological toxicity(From the start of the first-line treatment, evaluation was performed every cycle during the treatment and then every 3-6 months after the completion of the treatment, up to the start of subsequent-line treatment or death or 5 years.)

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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