Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
NCT Number: NCT01271439
This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
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Notify Me18 year–69 year
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 510060, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Other names: C225
Time frame: 3 Months
According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
Time frame: 1 year
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time frame: 3 years
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time frame: 1 year
disease free survival rate: from the time when finish treatment to first failure at any site.
Time frame: 3 years
disease free survival rate: from the time when finish treatment to first failure at any site.
Time frame: 1 year
overall survival rate: from the time when finish treatment to death of any cause.
Time frame: 3 years
overall survival rate: from the time when finish treatment to death of any cause.
Time frame: 3 years
all patients must have sufficient pretreatment tumor biopsy specimens.
Time frame: 3 years
collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.
Time frame: 3 years
all patients must have sufficient pretreatment tumor biopsy specimens.
Time frame: 3 years
all patients must have sufficient pretreatment tumor biopsy specimens.
Sun Yat-sen University
Other
A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
Acronym: REPLACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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