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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02263105
Eligibility Criteria:
Inclusion Criteria:
* Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
* All patients should complete radiation therapy for primary gliomas.
* MRI showed unequivocal evidence of tumor recurrence or progression.
* The time to be enrolled should be more than 90 days after the radiation therapy.
* Written informed consent
* Eastern Cooperative Oncology Group(ECOG) score: 0-2
* The patients with recurrent gliomas were treated without dose-dense TMZ therapy before enrollment.
* Surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted
Exclusion Criteria:
* Abnormal function of liver or renal (value more than 1.5 fold normal upper limit)
* Blood routing: Hb \< 90g/L, absolute neutrophil count≤1.5\*10\^9/L, platelet \< 100\*10\^9/L
* Pregnant or lactating women
* Allergic to administered drugs
* Radiation therapy in the previous 90 days before enrollment
* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
* Acute infection in need of antibiotics intravenously
* Participation in other clinical trials in the 90 days before enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02263105
Study Brief:
Protocol Section:
NCT02263105