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

NCT07448480 | Active Not Recruiting DMC

• 1 other identifier: 115522143967
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Recurrent Malignant Glioma; Glioblastoma; Anaplastic Astrocytoma; Pleomorphic Xanthoastrocytoma

Keywords

Recurrent glioma; High-grade glioma; Glioblastoma; Anaplastic astrocytoma; Pleomorphic Xanthoastrocytoma; Chemotherapy; Targeted therapy; Bevacizumab; Irinotecan; Temozolomide; Lomustine; Carboplatin; PCV; PC; CV; Procarbazine; Vincristine; Carmustine; BRAF inhibitors; MEK inhibitors; IDH1; IDH2; MGMT; 1p/19q codeletion; OS; PFS; RANO; Cohort study; Observational study; Retrospective study; Real-world data; RWD

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from the date of initial brain tumor diagnosis to the date of death from any cause or last contact with the patient (censored)

  From date of initial brain tumor diagnosis until date of death or last contact with the patient, assessed up to 5 years (censored)

Secondary Outcomes (5)

• Progression-Free Survival 1 (PFS1)

  From start of chemoradiotherapy until date of first progression or censoring at the start of first-line treatment, assessed up to 5 years

• Progression-Free Survival 2 (PFS2)

  From start of first-line therapy until date of progression or censoring at last instrumental follow-up, assessed up to 5 years

• Progression-Free Survival 3 (PFS3)

  From start of second-line therapy until date of progression or censoring at last instrumental follow-up, assessed up to 5 years

• Progression-Free Survival 4 (PFS4)

  From start of third-line therapy until date of progression or censoring at last instrumental follow-up, assessed up to 5 years

• Progression-Free Survival 5 (PFS5)

  From start of fourth-line therapy until date of progression or censoring at last instrumental follow-up, assessed up to 20 years

Study Arms (3)

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

Drug: Bevacizumab-Containing Regimens; Drug: Non-Bevacizumab Regimens; Drug: BRAF ± MEK Targeted Therapy

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.

Drug: Bevacizumab-Containing Regimens; Drug: Non-Bevacizumab Regimens

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.

Drug: Bevacizumab-Containing Regimens; Drug: Non-Bevacizumab Regimens; Drug: BRAF ± MEK Targeted Therapy

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.)

Astrocytoma, IDH-mutant; Glioblastoma, IDH-wildtype; Pleomorphic Xanthoastrocytoma

Non-Bevacizumab Regimens DRUG

Patients receiving conventional chemotherapy without bevacizumab (including temozolomide monotherapy, PCV regimen, nitrosoureas, platinum compounds, etc.)

Astrocytoma, IDH-mutant; Glioblastoma, IDH-wildtype; Pleomorphic Xanthoastrocytoma

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

Glioblastoma, IDH-wildtype; Pleomorphic Xanthoastrocytoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of approximately 1000 adult patients (aged ≥ 18 years) with histologically and molecularly confirmed diagnoses of malignant gliomas according to the WHO 2021 classification, including glioblastoma (IDH-wildtype, WHO grade 4), astrocytoma (IDH-mutant, WHO grade 3-4), and pleomorphic xanthoastrocytoma (WHO grade 2-3). All patients had documented disease recurrence or progression with available treatment-related data in medical records sufficient to assess at least one of the study outcome measures (OS, PFS1, PFS2, PFS3, PFS4, or PFS5). Patients were treated at the N.N. Blokhin National Medical Research Center of Oncology between 2005 and 2025. Patients with absent molecular-genetic confirmation according to WHO 2021 classification, insufficient treatment-related data, prior participation in clinical trials with unblinded investigational agents where data cannot be extracted, or synchronous primary malignant neoplasms were excluded from the analysis

You may qualify if:

• Age ≥ 18 years at the time of initial brain tumor diagnosis;
• Histologically confirmed diagnosis of malignant glioma, including:
• Glioblastoma, IDH-wildtype (WHO grade 4)
• Astrocytoma, IDH-mutant (WHO grade 3-4)
• Pleomorphic xanthoastrocytoma (WHO grade 2-3)
• Molecularly confirmed diagnosis according to WHO 2021 classification (with available data on IDH1/2, BRAF, 1p/19q, and MGMT status where applicable);
• Documented disease recurrence or progression with available treatment-related data in medical records to assess at least one of the study outcome measures

You may not qualify if:

• Age \< 18 years at initial diagnosis;
• Absence of molecular-genetic confirmation of the tumor (according to WHO 2021 classification);
• Lack of documented disease recurrence or progression, or insufficient treatment-related data in medical records to assess at least one of the study outcome measures;
• Prior participation in clinical trials with unblinded investigational agents where data cannot be extracted (except where data are available and verifiable);
• Synchronous primary malignant neoplasms.

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

Blokhin's Russian Cancer Research Center

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• David Naskhletashvili, MD, PhD

  N.N. Blokhin National Medical Research Center of Oncology

  PRINCIPAL INVESTIGATOR

• David Khalafyan, MD

  N.N. Blokhin National Medical Research Center of Oncology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and for 5 years following publication of the primary results
• Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal for non-commercial, academic research. A data sharing agreement must be signed, ensuring compliance with institutional ethics and data protection policies

Locations

RU (1)