This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
Scheme: Eligible fosaprepitant sensitive (complete response \[defined as no emesis and no use of rescue antiemetics\] during the overall phase \[0 to 120 hours\] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio. * Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy. * Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
the proportion of subjects with complete response (CR) overall
defined as no emesis and no use of rescue therapy
Time frame: 7 weeks
the proportion of subjects with complete control (CC) overall
defined as no emesis and no use of rescue therapy and no significant nausea
Time frame: 7 weeks
the proportion of subjects with sustained no emesis overall
Time frame: 7 weeks
the proportion of subjects with no nausea overall
Time frame: 7 weeks
the proportion of subjects with no significant nausea overall
defined as no or mild nausea
Time frame: 7 weeks
the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin
defined as no emesis and no use of rescue therapy
Time frame: 24 hours
the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin
defined as no emesis and no use of rescue therapy
Time frame: 120 hours
the mean time to first emetic episode
Time frame: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
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Time frame: 7 weeks
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall
Time frame: 7 weeks