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

NCT04472403 | Unknown

• 1 other identifier: B2019-201-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Metastasis; Chemotherapy; Survival

Outcome Measures

Primary Outcomes (3)

• 5-year overall survival

  The period until death is detected.

  5 years after diagnosis of metastasis

• 5-year subsequent-line treatment-free survival

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

  5 years after the start of the first-line treatment

• 5-year survival without symptoms and toxicity

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

  5 years after diagnosis of metastasis

Secondary Outcomes (1)

• 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.

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

All patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed distant metastasis during 2006-2017 and receiving treatment in our hospital.

You may qualify if:

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

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
• Without 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; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Shuo-han Zheng, MD

CONTACT

+8613826478924; zhengsh1@sysucc.org.cn

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: July 11, 2020
• First Posted: July 15, 2020
• Study Start: November 26, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

CN (1)