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

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab

• Registration Number: NCT01326559
• Lead Sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-31
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental 1	Docetaxel, Cisplatin, 5-FU and Cetuximab	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

Primary Outcome Measures

Name	Time	Method
Complete response rate	5 years	Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.

Secondary Outcome Measures

Name	Time	Method
Overall response rate	5 years	Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.
Locoregional and distant control rate	5 years	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.
Progression free survival	5 years	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.
Overall survival	5 years	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.

Trial Locations

Locations (4)

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

Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong; 🇨🇳 Hong Kong, China