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

NCT04764149 | Unknown

• 1 other identifier: 2020-FXY-429
• Study Type: observational
• Target: 801
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

  The period until death is detected.

  5 years after diagnosis of recurrent

Study Arms (2)

PFll Group

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.

Non-PFLL Group

Patients were treated with other platinum-based chemotherapy every 21 days including: PF regimen: 5-fluorouracil at a dose of 1,000 mg/m2 daily by continuous intravenous infusion on days 1-4 and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. GP regimen: gemcitabine at a dose of 1,000 mg/m2 by intravenous infusion on days 1, 8, and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. TP regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1 and intravenous infusion of cisplatin at a dose of 75 mg/m2 on day 1. TPF regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1; cisplatin intravenous infusion at a dose of 75 mg/m2 on day 1 and continuous intravenous infusion of 5-FU at a dose of 750 mg/m2 daily on days 1-5. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yun-fei Xia, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, MD

CONTACT

+8613602805461; xiayf@sysucc.org.cn

Ying-hong Wei, MD

CONTACT

+8619868588050

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: November 1, 2019
• Primary Completion: January 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

CN (1)