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

Phase 3Active Not RecruitingNCT03840421

Sun Yat-sen University468 enrolled

Overview

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.

Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free survival (LRRFS), initial response rates after treatments, toxic effects and quality of life (QoL).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

468

Conditions

Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms Nasopharyngeal Diseases Head and Neck Neoplasm

Interventions

gemcitabine and cisplatinDRUG

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

cisplatin and fluorouracilDRUG

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

IMRTRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

progress-free survival (PFS)

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

Time frame: 3 years

Secondary Outcomes

Distant Metastasis-Free Survival (DMFS)

The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

Time frame: 3 years

Overall Survival (OS)

The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

Time frame: 3 years

Locoregional Relapse-Free Survival (LRRFS)

The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Time frame: 3 years

Number of participants with adverse events

Incidence of acute and late toxicity

Time frame: up to 3 years

Data from ClinicalTrials.gov

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