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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02854735
Eligibility Criteria:
Inclusion Criteria:
1. Biopsy-proven head and neck (SCC), surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsy.
2. 2010 7th edition AJCC stage III, IVA (T4N0-2) and IVB (any T, N3).
3. Well-informed and accepted treatment of CCRT.
4. Age 20-70 years old.
5. Negative pregnancy test for women of childbearing potential.
6. Adequate hematopoietic or organ function which is amenable for chemotherapy:
* A leukocyte count ≥3000/L
* Platelet count ≥100,000/L.
* Serum bilirubin level ≦ 1.5mg/dL
* Serum creatinine level ≦1.6 mg/dL or creatinine clearance ≥ 60 mL/min/1.73 m2.
* ALT/AST ≦ 3X ULN
9\. Ability to understand and willingness to be enrolled in our study and sign a written informed consent document
Exclusion Criteria:
1. NPC is excluded from this study.
2. Patients have acute medical conditions (such as bacterial or viral infection or active cardiopulmonary disease) that may be incapable of having regular image study.
3. Patients are under regular steroid or hyperthyroid medications, which may have great impact on the whole body metabolism.
4. Patients are under-nutrient and they need to have regular liquid oral nutrition formulas support.
5. Patient that have dementia or pregnant.
6. Patients not expecting to comply with follow up.
7. Patient not suitable for chemotherapy.
8. Patient not suitable for MRI, such as claustrophobia, previous metal implantation, previous cardiac pacemaker implantation, inability to comply with MRI instructions and poor renal function.
9. Received barium study within a week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02854735
Study Brief:
Protocol Section:
NCT02854735