Status:
COMPLETED
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sichuan Cancer Hospital and Research Institute
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
Eligibility Criteria
Inclusion
- Informed consent form signed prior to study entry
- Age between 18-69 years old
- Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
- Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
- Primary tumor measurable
- KPS score ≥80
- Expected life span ≥6 months
- Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
- Adequate liver function: ALAT/ASAT\<1.5 × upper limit of normal (ULN), bilirubin \<1.5×ULN
- Adequate renal function: Creatinine Clearance \< 1.5×ULN
Exclusion
- Evidence of distant metastatic disease
- Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
- Previous radiotherapy for the primary tumor or lymph nodes
- Previous exposure to epidermal growth factor-targeted therapy
- Prior chemotherapy or immunotherapy for the primary tumor
- Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
- Any investigational agent prior to the 1st study medication
- Participation in another clinical study within the 30 days prior to Inclusion in this study.
- Peripheral neuropathy \> grade 1
- Known grade 3 or 4 allergic reaction to any of the study treatment
- History of severe pulmonary or cardiac disease
- Creatinine Clearance \< 30ml/min
- Know drug abuse / alcohol abuse
- Legal incapacity or limited legal capacity
- Active systemic infection
- Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
- Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
- Pregnancy (confirmed by serum or urine β-HCG) or lactation period
- Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00700440
Start Date
July 1 2008
End Date
April 1 2009
Last Update
March 26 2010
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080