Brief Title
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Metastatic Nasopharyngeal Carcinoma
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
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).
Study Type
Observational
Primary Outcome
5-year overall survival
Secondary Outcome
Haematological toxicity
Condition
Nasopharyngeal Carcinoma
Study Arms / Comparison Groups
PFLL Group
Description: Patients were treated with PFLL regimen: 5-fluorouracil intravenous infusion at 200mg/m2/d for 30 continuous days and intravenous infusion of platinum (cisplatin 70 mg/m2 or nedaplatin 80/m2 or lobaplatin 30 mg/m2) on day 1 and day 28, every 60 days. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2000
Start Date
November 26, 2019
Completion Date
December 2020
Primary Completion Date
August 2020
Eligibility Criteria
Inclusion Criteria:
- Nasopharyngeal carcinoma diagnosed by pathology or cytology
- Distant metastasis confirmed by Radiographic assessments or pathology.
- Patients ever received systemic chemotherapy.
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
- Without other malignances
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Yun-fei Xia, MD, +8613602805461, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04472403
Organization ID
B2019-201-01
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Yun-fei Xia, MD, Principal Investigator, Sun Yat-sen University
Verification Date
July 2020