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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)

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel, Cisplatin, 5-FU and Cetuximab
Sponsored by
Hong Kong Nasopharyngeal Cancer Study Group Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring induction chemotherapy, docetaxel, cisplatin, fluorouracil, cetuximab, intensity-modulated radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental 1

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall response rate
Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.
Locoregional and distant control rate
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
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
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.

Full Information

First Posted
March 22, 2011
Last Updated
August 13, 2017
Sponsor
Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborators
The University of Hong Kong, Sanofi, Merck Sharp & Dohme LLC, Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01326559
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborators
The University of Hong Kong, Sanofi, Merck Sharp & Dohme LLC, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 To determine the overall response rate. To determine the locoregional and distant control rate To determine the progression-free survival (PFS) To determine the overall survival (OS) To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
induction chemotherapy, docetaxel, cisplatin, fluorouracil, cetuximab, intensity-modulated radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental 1
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Cisplatin, 5-FU and Cetuximab
Intervention Description
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)
Primary Outcome Measure Information:
Title
Complete response rate
Description
Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.
Time Frame
5 years
Title
Locoregional and distant control rate
Description
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.
Time Frame
5 years
Title
Progression free survival
Description
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.
Time Frame
5 years
Title
Overall survival
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Anne W.M., F.R.C.R.(HK)
Organizational Affiliation
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong
City
Hong Kong
Country
China
Facility Name
Department of Clinical Oncology, Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong
City
Hong Kong
Country
China
Facility Name
Department of Oncology, Princess Margaret Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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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)

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