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

Hong Kong Nasopharyngeal Cancer Study Group Limited

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01326559

NPC-1001 trial

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Experimental 1

Experimental group

Description:

Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16

Treatment:

Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab