Brief Title
Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)
Official Title
Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete response rate
Secondary Outcome
Overall response rate
Condition
Nasopharyngeal Carcinoma
Intervention
Docetaxel, Cisplatin, 5-FU and Cetuximab
Study Arms / Comparison Groups
Experimental 1
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
June 2010
Completion Date
March 2017
Primary Completion Date
December 2016
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Lee Anne W.M., F.R.C.R.(HK), ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01326559
Organization ID
NPC-1001 trial
Responsible Party
Principal Investigator
Study Sponsor
Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborators
The University of Hong Kong
Study Sponsor
Lee Anne W.M., F.R.C.R.(HK), Principal Investigator, Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Verification Date
August 2017