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An Observational Study of Olanzapine Combined with Radiotherapy and Temozolomide Chemotherapy in the Treatment of Postoperative Brain Glioma Patients with Mania

An Observational Study of Olanzapine Combined with Radiotherapy and Temozolomide Chemotherapy in the Treatment of Postoperative Brain Glioma Patients with Mania

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107107
Enrollment
Unknown
Registered
2025-08-04
Start date
2023-09-10
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Interventions

Case group: 30 cases of postoperative manic glioma patients were treated with temozolomide combined with olanzapine concurrent chemoradiotherapy
:None
Control group: 30 cases of postoperative glioma patients who received conventional radiotherapy and chemotherapy in the past.:None

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Aged between 18 and 65 years, regardless of gender 2: Diagnosed with malignant glioma, with pathological types including anaplastic astrocytoma or glioblastoma, clinical staging of high-grade glioma (Grade III–IV) or high-risk low-grade glioma (Grade I–II). High-risk factors include astrocytoma, age >40 years, Karnofsky Performance Status (KPS) 6 cm, tumor crossing the midline, moderate to severe preoperative neurological deficits, and tumor location in the temporal, parietal, occipital, or frontal lobes 3: Treatment regimen involving radiotherapy combined with concurrent adjuvant temozolomide chemotherapy 4: Postoperative clinical diagnosis of manic episode or psychiatric symptoms 5: Karnofsky Performance Status (KPS) >60 6: No missing key data, defined as indicators that affect study execution and outcome evaluation, including gender, pathological type, age, tumor location, clinical stage, treatment information, Mini-Mental State Examination (MMSE), cranial MRI imaging, progression-free survival (PFS), and overall survival (OS) 7: Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1: Patients who received radiotherapy, chemotherapy, or other antitumor drug treatments prior to surgery 2: Patients with digestive or hematologic diseases within the past 6 months, or those with decreased blood cell counts and neutropenia due to any cause, as well as patients who have undergone bone marrow transplantation 3: Patients allergic to alkylating agents such as temozolomide 4: Pregnant or lactating patients 5: Patients with severe renal or hepatic impairment 6: Patients with cardiovascular or cerebrovascular diseases prone to hypotension, epilepsy, prostatic hyperplasia, or paralytic ileus 7: Patients who drive vehicles or operate machinery.

Design outcomes

Primary

MeasureTime frame
Overall Response Rate (ORR) ;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactRikang Wang

Peking University Shenzhen Hospital

wrk168ok@163.com+86 755 8392 3333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026