Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT07448480
Status
Active Not Recruiting

Conditions

  • Anaplastic Astrocytoma
  • Glioblastoma
  • Pleomorphic Xanthoastrocytoma
  • Recurrent Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab-Containing Regimens — DRUG
    Patients receiving any line of therapy that includes bevacizumab (alone or in combination with other agents such as temozolomide, irinotecan, lomustine, carboplatin, etc.)
  • Non-Bevacizumab Regimens — DRUG
    Patients receiving conventional chemotherapy without bevacizumab (including temozolomide monotherapy, PCV regimen, nitrosoureas, platinum compounds, etc.)
  • BRAF ± MEK Targeted Therapy — DRUG
    Patients harboring BRAF mutations receiving targeted therapy with BRAF inhibitors (dabrafenib, vemurafenib) alone or in combination with MEK inhibitors (trametinib, cobimetinib), with or without concomitant chemotherapy

Study Details

GLIOTARG trial is a large single-center observational cohort study designed to investigate chemotherapy and targeted therapy outcomes in recurrent malignant gliomas. The study includes patients with molecularly confirmed diagnoses according to the World Health Organization (WHO) 2021 classification of Central Nervous System (CNS) tumors: glioblastomas (IDH-wildtype, WHO grade 4), astrocytomas (IDH-mutant, WHO grade 3-4), and pleomorphic xanthoastrocytomas (WHO grade 2-3).

Key Dates

First listed
Mar 4, 2026
Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
1,000 participants (actual)

Arms

  • Arm: Glioblastoma, IDH-wildtype
    Patients with histologically and molecularly confirmed diagnosis of glioblastoma according to the WHO 2021 classification. Tumors are characterized by absence of IDH1/2 mutations (IDH-wildtype), WHO grade 4, and typically exhibit one or more of the following molecular features: TERT promoter mutation, EGFR gene amplification, +7/-10 chromosome copy-number changes. This cohort includes only de novo (primary) glioblastomas. Astrocytomas that have secondarily progressed to glioblastoma (IDH-mutant) were excluded
  • Arm: Astrocytoma, IDH-mutant
    Patients with histologically and molecularly confirmed diagnosis of astrocytoma according to the WHO 2021 classification. Tumors are characterized by presence of IDH1 or IDH2 mutations (IDH-mutant), WHO grade 3 or 4, and absence of 1p/19q codeletion. Grade 4 astrocytomas (formerly known as "IDH-mutant glioblastoma") additionally exhibit microvascular proliferation and/or necrosis.
  • Arm: Pleomorphic Xanthoastrocytoma
    Patients with histologically and molecularly confirmed diagnosis of pleomorphic xanthoastrocytoma according to the WHO 2021 classification. Tumors are characterized by pleomorphic, lipidized astrocytes, often with BRAF V600E mutations (present in approximately 60-70% of cases). Both WHO grade 2 and grade 3 (anaplastic) variants were included. Anaplastic features include increased mitotic activity (≥ 5 mitoses per 10 high-power fields) and may show necrosis. All pleomorphic xanthoastrocytomas, regardless of BRAF mutation status, were included.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of initial brain tumor diagnosis until date of death or last contact with the patient, assessed up to 5 years (censored) ]

Related Studies