GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT03840421 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2018-FXY-140
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasm

Keywords

gemcitabine; cisplatin; fluorouracil

Outcome Measures

Primary Outcomes (1)

• progress-free survival (PFS)

  Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

  3 years

Secondary Outcomes (4)

• Distant Metastasis-Free Survival (DMFS)

  3 years

• Overall Survival (OS)

  3 years

• Locoregional Relapse-Free Survival (LRRFS)

  3 years

• Number of participants with adverse events

  up to 3 years

Study Arms (2)

gemcitabine and cisplatin

EXPERIMENTAL

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Drug: gemcitabine and cisplatin; Radiation: IMRT; Drug: cisplatin

cisplatin and fluorouracil

ACTIVE COMPARATOR

Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Drug: cisplatin and fluorouracil; Radiation: IMRT; Drug: cisplatin

Interventions

gemcitabine and cisplatin DRUG

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Also known as: gemcitabine and cisplatin (GP)

gemcitabine and cisplatin

cisplatin and fluorouracil DRUG

Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Also known as: cisplatin and fluorouracil (PF)

cisplatin and fluorouracil

IMRT RADIATION

Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor

cisplatin and fluorouracil; gemcitabine and cisplatin

cisplatin DRUG

IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Also known as: cisplatin（DDP）

cisplatin and fluorouracil; gemcitabine and cisplatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
• Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition）
• Male and no pregnant female
• Age between 18-65
• Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
• Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<2.0×upper limit of normal (ULN)
• Adequate renal function: creatinine clearance ≥60 ml/min
• Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
• Without radiotherapy or chemotherapy
• Patients must give signed informed consent

You may not qualify if:

• Evidence of relapse or distant metastasis
• History of prior malignancy or previous treatment for NPC
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
• Pregnancy or lactation

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Guangdong Provincial People's Hospital, China: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasms

Interventions

Gemcitabine; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones

Study Officials

• Ming-Yuan Chen, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: April 3, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

CN (1)