Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects (CHANCE)
Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects.
Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects.
Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.
|Squamous Cell Carcinoma of the Head and Neck||Biological: Cetuximab + concomitant boost radiotherapy||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects|
- Best Overall Response (BOR) [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit ]Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant ]Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).
|Study Start Date:||February 2009|
|Study Completion Date:||May 2014|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
All eligible subjects will receive cetuximab treatment only during week 1 of the treatment course and concomitant cetuximab and boost radiotherapy (RT) during week two to week seven of the treatment course
Biological: Cetuximab + concomitant boost radiotherapy
Cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially
Other Name: Erbitux®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012258
|Fujian Provincial Tumor Hospital|
|Fuzhou, Fujian, China|
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Xiangya Hospital of Central South University|
|Changsha, Hunan, China|
|Sun Yat-sen University Cancer Center|
|Zhejiang Provincial Cancer Hospital|
|Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine|
|Union Hospital of Tongji Medical College, Huazhong University of Science and Technology|
|Wuhan, Hubei, China|
|Zhongnan Hospital of Wuhan University|
|Wuhan, Hubei, China|
|Principal Investigator:||Li Gao||Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China|
|Study Director:||Junliang Cai||Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany|
|Principal Investigator:||Guozhen Xu||Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China|