Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
- Registration Number
- NCT04636632
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Stage II - IVa NPC patients (according to the 8th AJCC edition)
- Male and no pregnant female
- Scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin
- 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)
- Age between 18-70
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- Adequate renal function: creatinine clearance ≥60 ml/min
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
- Without radiotherapy or chemotherapy
- Patients must give signed informed consent
- Evidence of relapse or distant metastasis
- Pregnancy or lactation
- History of prior malignancy or previous treatment for NPC
- Had other current malignant diagnoses apart from non-melanoma skin cancers
- Emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication
- Drugs with antiemetic activity were not allowed for the 24 h before receiving the first dose of study medication
- Known history of central nervous system disease (e.g., a seizure disorder or brain metastases )
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weekly Arm fosaprepitant fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy Triweekly Arm fosaprepitant fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy
- Primary Outcome Measures
Name Time Method the proportion of subjects with complete response (CR) overall 7 weeks defined as no emesis and no use of rescue therapy
- Secondary Outcome Measures
Name Time Method the proportion of subjects with complete control (CC) overall 7 weeks defined as no emesis and no use of rescue therapy and no significant nausea
the proportion of subjects with sustained no emesis overall 7 weeks the proportion of subjects with no nausea overall 7 weeks the proportion of subjects with no significant nausea overall 7 weeks defined as no or mild nausea
the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin 24 hours defined as no emesis and no use of rescue therapy
the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin 120 hours defined as no emesis and no use of rescue therapy
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall 7 weeks the mean time to first emetic episode 7 weeks Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall 7 weeks
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China