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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01479504
Eligibility Criteria:
Inclusion Criteria:
* histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
* non-keratinizing or undifferentiated type
* clinical stage III-IVb (UICC 7th edition)
* age between 18-70
* satisfactory performance status: Karnofsky scale (KPS) \> 70.
* hemoglobin \> 100g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L
* serum creatinine level \< 1.6 mg/dL or creatinine clearance ≥ 60 mL/min.
* normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5ULN
* patients must be informed of the investigational nature of this study and give written informed consent.
* anticipated life span more than 6 month
Exclusion Criteria:
* primary treatment with palliative intent
* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases
* pregnancy or lactation
* history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
* prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
* prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
* 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:
NCT01479504
Study Brief:
Protocol Section:
NCT01479504