Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT04472403
Status:
UNKNOWN
Last Update Posted:
2020-07-20
First Post:
2020-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Metastatic Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: