Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: C225 (cetuximab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00700440

PPRA-RTOG 0001

EMR62202-770

Details and patient eligibility

About

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

Enrollment: 100 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Cetuximab

Experimental group

Description:

400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy

Treatment:

Drug: C225 (cetuximab)