Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Recurrent Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    801
  • sponsor
    Sun Yat-sen University
Updated on 5 March 2021

Summary

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.

Description

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).

Details
Condition Carcinoma, Nasopharyngeal Cancer, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, nasopharyngeal carcinoma
Clinical Study IdentifierNCT04764149
SponsorSun Yat-sen University
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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