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Completed

NCT Number: NCT01326559

Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local 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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docetaxel, Cisplatin, 5-FU and Cetuximab

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Mar 31, 2011
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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