The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma
Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Neoadjuvant chemotherapy regimen with cisplatin
Neoadjuvant chemotherapy regimen with Fluorouracil
Intensity-Modulated Radiation Therapy
Taichung Vaterans General Hospital
Taichung, Taiwan
RECRUITINGTumor response by RECIST version 1.1
According to RECIST version 1.1
Time frame: 5 years
Overall survival
Time frame: 5 years
Acute toxicity by CTCAE deifnition
According to CTCAE deifnition
Time frame: 6 months
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Neoadjuvant chemotherapy regimen with Leucovorin