Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma|
- 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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.
- 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Drug: C225 (cetuximab)
one week before and then weekly during radiotherapy
Other Name: Erbitux
|Cancer Center, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||Tai-xiang Lu, M.D.||Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University|
|Principal Investigator:||Tong-yu Lin, M.D., PhD||Departments of Chemotherapy, Cancer Center, Sun Yat-sen University|