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:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT00181220
Eligibility Criteria:
Inclusion Criteria:
All subjects must fulfill the following criteria to be eligible for study admission:
* Subjects are of age 18 years and above
* Biopsy proven nasopharyngeal carcinoma - WHO type 3
* Must have tumor which is accessible to biopsy
* For patients with disease localized to the PNS, the lesion must be visualized by endoscopy
* Subjects with metastatic disease with disease accessible to biopsy in the PNS if they are deemed by their treating physicians not to require treatment for at least two weeks.
* An ECOG performance status of 0-2
* For sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial
* Must be able to give informed consent
Exclusion Criteria:
* For patients with localized NPC, PNS lesions that cannot be visualized by endoscopy
* Patients with disease inaccessible to biopsy
* History of anaphylaxis after exposure to valproic acid
* Hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. AST (SGOT) and ALT (SGPT) 3x upper limit of normal
* Hemoglobin 8g/dl, Absolute neutrophil count 1500 cells/mm, and Platelet count 100,000 /mm
* Creatinine 3x upper limit of normal
* PT/PTT blood test result not within normal range
* Patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol
* ECOG Performance status 3-4
* Patients who are pregnant or breast feeding (Sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial)
* Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00181220
Study Brief:
Protocol Section:
NCT00181220