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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-08-16

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Docetaxel, Cisplatin, 5-FU and Cetuximab

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)

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Hong Kong Nasopharyngeal Cancer Study Group Limited

    lead OTHER

Principal Investigators

  • Lee Anne W.M., F.R.C.R.(HK) · Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326559 on ClinicalTrials.gov