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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT02507232
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed low-grade glioma including astrocytoma grade 2, oligodendroglioma grade 2, or oligoastrocytoma grade 2.
* Tumor is supratentorially located and measureable.
* Disease that has not received prior radiation, radiosurgery, chemotherapy, or other investigational treatment directed at the brain tumor at any time. Previous surgical procedures is allowed.
* Age ≥ 18 years.
* Life expectancy \> 12 weeks.
* Either not receiving steroids for disease symptoms or are on stable dose of steroids for at least 5 days.
* Karnofsky Performance Status (KPS) ≥ 60%
* Adequate hematologic function evidenced by:
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 9.0 g/dL
* Adequate renal function evidenced by:
* AST/SGOT and ALT/SPGT ≤ 2.5 X institutional upper limit of normal
* Total bilirubin ≤ 1.5 x institution's ULN
* Serum creatinine ≤ 1.5 x institution's ULN
Exclusion Criteria:
* Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors are not eligible.
* Current or anticipated use of other investigational agents.
* Implanted electronic medical device in the brain (e.g., deep brain stimulator, vagus nerve stimulator, programmable shunt).
* Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing.
* Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
* Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
* Pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02507232
Study Brief:
Protocol Section:
NCT02507232