Study Objective: Primary 1\. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT). Secondary 1. To determine the overall response rate. 2. To determine the locoregional and distant control rate 3. To determine the progression-free survival (PFS) 4. To determine the overall survival (OS) 5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Induction phase (Weeks 1-9): Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles Concurrent phase (weeks 10-16): Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16) Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16) IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)
Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong
Hong Kong, China
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, China
Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong
Hong Kong, China
Department of Oncology, Princess Margaret Hospital
Hong Kong, China
Complete response rate
Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.
Time frame: 5 years
Overall response rate
Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.
Time frame: 5 years
Locoregional and distant control rate
Defined as the proportion of subjects with no local or nodal progression or recurrence and no distant disease progression or recurrence compared to the overall treated group.
Time frame: 5 years
Progression free survival
Defined as the time in months from first dose of cetuximab until PD is observed or death occurs due to any cause within 90 days after the last tumour assessment or first cetuximab dose.
Time frame: 5 years
Overall survival
Defined as the time in months from first dose of cetuximab to the date of death is observed. If subject has not died, the survival time will be censored on the last date the subject was known to be alive.
Time frame: 5 years
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