To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck
To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting induced by chemoradiotherapy in HNSCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.
National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
Beijing, China
Complete response rate
no vomiting and nausea, and no use of rescue therapy
Time frame: up to 8 weeks
Complete response rate
no vomiting and nausea, and no use of rescue therapy
Time frame: up to 3 weeks
Complete response rate
no vomiting and nausea, and no use of rescue therapy
Time frame: up to 6 weeks
European Organization for Research on Treatment of Cancer Quality of life questionnaire
Quality of life questionnaire core 30 chinese version is used. The total score is reported, and the high values represent a worse outcome.
Time frame: up to 12 weeks
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