Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT04636632
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04636632
Study Brief:
Protocol Section:
NCT04636632