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Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)

NCT01326559

CompletedPhase 2

Sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited

Conditions: Nasopharyngeal Carcinoma

Interventions: Docetaxel, Cisplatin, 5-FU and Cetuximab

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy
* Age \> 18 to \< 70 years
* Performance status: \< 1 by ECOG System (Appendix I)
* Adequate bone marrow \& renal function
* Patients having Bilirubin =\< 1.5 x ULN, ASAT \& ALST=\< 1.5 x ULN, Serum creatinine=\< 1.25 x ULN and / or Creatinine clearance \>= 60ml/min
* Patients having WBC \>= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets \>= 100 x10e9/L,Hemoglobin \>=10g/dL
* Signed written informed consent
* Patients must have at least one measurable lesion

Exclusion Criteria:

* Use of investigational agent within the past 28 days
* Pre-treatment with an anti-EGFR drug
* Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
* History of severe pulmonary diseases
* Active infection or other systemic disease under poor control
* Uncontrolled chronic neuropathy
* Know grade 3 or 4 allergic reaction to any of the components of the treatment
* Estimated life expectancy is less than 3 months
* Pregnancy or breast feeding

Locations (4)

Hong Kong, China
Hong Kong, China
Hong Kong, China
Hong Kong, China