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

Phase 2
18 Years
65 Years
Not Enrolling
Nasopharyngeal Carcinoma

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events as a measure of safety and tolerability

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Gwo Fuang Ho, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Malaya


Malaysia: Ministry of Health

Study ID:

EMR 62202-832



Start Date:

May 2010

Completion Date:

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Locally advanced nasopharyngeal carcinoma
  • Neoadjuvant chemotherapy
  • Chemoradiation
  • Cetuximab
  • Carcinoma
  • Nasopharyngeal Neoplasms