Brief Title
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with adverse events as a measure of safety and tolerability
Secondary Outcome
Objective response rate
Condition
Nasopharyngeal Carcinoma
Intervention
Cetuximab
Study Arms / Comparison Groups
Cetuximab and chemotherapy
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
3
Start Date
May 2010
Completion Date
May 2015
Primary Completion Date
May 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Gwo Fuang Ho, FRCR, ,
Location Countries
Malaysia
Location Countries
Malaysia
Administrative Informations
NCT ID
NCT01230476
Organization ID
EMR 62202-832
Responsible Party
Principal Investigator
Study Sponsor
University of Malaya
Collaborators
Merck Serono International SA
Study Sponsor
Gwo Fuang Ho, FRCR, Principal Investigator, University Malaya
Verification Date
October 2019