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

August 13, 2017 updated by: Dr. ANNE W M LEE, Hong Kong Nasopharyngeal Cancer Study Group Limited

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Department of Clinical Oncology, Queen Mary Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong
      • Hong Kong, China
        • Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong
      • Hong Kong, China
        • Department of Oncology, Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 5 years
Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Collaborators

Sanofi
The University of Hong Kong
Merck Sharp & Dohme LLC
Roche Pharma AG

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 13, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-1001 trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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