Head and Neck Neoplasm, Nasopharyngeal Carcinoma, Nasopharyngeal Diseases, Nasopharyngeal Neoplasms
Conditions
Keywords
gemcitabine, cisplatin, fluorouracil
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.
Detailed description
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).
Interventions
DRUGgemcitabine and cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
DRUGcisplatin and fluorouracil
Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
RADIATIONIMRT
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
DRUGcisplatin
IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival (PFS) | 3 years | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS) | 3 years | 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. |
| Overall Survival (OS) | 3 years | 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. |
| Locoregional Relapse-Free Survival (LRRFS) | 3 years | 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. |
| Number of participants with adverse events | up to 3 years | Incidence of acute and late toxicity |
Countries
China
Outcome results
None listed