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Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01230476
Recruitment Status : Terminated
First Posted : October 29, 2010
Last Update Posted : October 7, 2019
Merck Serono International SA
Information provided by (Responsible Party):
Ho Gwo Fuang, University of Malaya

Brief Summary:
Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Cetuximab and chemotherapy
2 cycles of neoadjuvant cisplatin and 5FU (3 weekly), given with weekly cetuximab, followed by 7 doses of weekly cisplatin and cetuximab concurrent with radiotherapy
Drug: Cetuximab
Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.

Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 1 year ]
    Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings

  2. Progression and overall survival [ Time Frame: 1 year ]
    To assess the PFS and OS at one year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • Inpatients or outpatients, 18-65 years of age
  • Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
  • Evidence of unidimensional measurable disease as per RECIST criteria
  • No systemic metastatic disease (M0)
  • ECOG performance status of 0 or 1 at study entry
  • Effective contraception
  • White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
  • Total bilirubin ≤ 1.5x upper reference range
  • AST & ALT ≤ 1.5x upper reference range
  • Glomerular filtration rate > 60 ml/min
  • Serum creatinine ≤ 1.25x upper reference range

Exclusion Criteria:

  • Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
  • Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
  • Known hypersensitivity reaction to any of the components of study treatments
  • Pregnancy or lactation period
  • Systemic metastatic disease
  • Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • Peripheral neuropathy > grade 1
  • Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
  • Known alcohol or drug abuse
  • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
  • Legal incapacity or limited legal capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230476

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University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Merck Serono International SA
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Principal Investigator: Gwo Fuang Ho, FRCR University Malaya
  Study Documents (Full-Text)

Documents provided by Ho Gwo Fuang, University of Malaya:
Study Protocol  [PDF] January 4, 2019

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Responsible Party: Ho Gwo Fuang, Medical Lecturer, University of Malaya Identifier: NCT01230476    
Other Study ID Numbers: EMR 62202-832
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Keywords provided by Ho Gwo Fuang, University of Malaya:
Locally advanced nasopharyngeal carcinoma
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents