Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Drug: C225 (cetuximab)
- Registration Number
- NCT00700440
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetuximab C225 (cetuximab) 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
- Primary Outcome Measures
Name Time Method 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy 3 months The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.
- Secondary Outcome Measures
Name Time Method 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival 5 year
Trial Locations
- Locations (1)
Cancer Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China