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Clinical Trial NCT06492486 (GLADIATOR) for Diffuse Glioma, Glioblastoma, Adaptive Radiotherapy, Artificial Intelligence is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow (GLADIATOR) Phase 2 60 Adaptive Design

Not yet recruiting
Clinical Trial NCT06492486 (GLADIATOR) is designed to study Treatment for Diffuse Glioma, Glioblastoma, Adaptive Radiotherapy, Artificial Intelligence. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 30 November 2025 until the study accrues 60 participants. Led by Tata Memorial Centre, this study is expected to complete by 30 July 2028. The latest data from ClinicalTrials.gov was last updated on 16 September 2025.
Brief Summary
Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a unifo...Show More
Detailed Description
Glioblastoma multiforme (GBM) represents grade 4 diffuse gliomas accounting for the most common primary malignant central nervous system (CNS) tumors in adults . GBM is treated with radiotherapy (RT) and concurrent chemotherapy following maximal safe resection, with a median survival of approximately 15-18 months . GBM harbors significant intratumoral heterogeneity with areas of multiclonal and hypoxic areas renderin...Show More
Official Title

Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow

Conditions
Diffuse GliomaGlioblastomaAdaptive RadiotherapyArtificial Intelligence
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • GLADIATOR
  • 4384
NCT ID Number
NCT06492486
Start Date (Actual)
2025-11-30
Last Update Posted
2025-09-16
Completion Date (Estimated)
2028-07-30
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalStratum A (IDH-negative GBM)
Adaptive radiotherapy
Adaptive Radiotherapy
Volumetric and biological adaptive radiotherapy will be delivered based on interval imaging with MRI and PET scan during treatment.
ExperimentalStratum B (IDH-mutant astrocytoma or oligodendroglioma)
Adaptive radiotherapy
Adaptive Radiotherapy
Volumetric and biological adaptive radiotherapy will be delivered based on interval imaging with MRI and PET scan during treatment.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of patients undergoing volumetric and biological adaptation. Cumulative rate of symptomatic radionecrosis (RN) at 2 years.
Proportion of patients where modification of radiation plan was done.
2 years
Cumulative rate of symptomatic radionecrosis at 2 years
Patients developing symptomatic radionecerosis will be analyzed using Kaplan-Meier survival method.
4 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression free survival
Progression free survival will be analyzed using Kaplan Meier method.
4 years
Overall survival
Overall survival will be analyzed using Kaplan Meier method.
4 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).

Age: 18-70 years. Karnofsky Performance Scale (KPS) ≥60

  • Multifocal or multicentric disease Not eligible for radical intent radiation. IDH status is unknown or uninterpretable (IHC or gene sequencing). Use of prior radiotherapy to the head-neck region or brain or chemotherapy. Contraindication/unable to undergo MRI or PET scan during radiation.
Tata Memorial Centre logoTata Memorial Centre
Study Responsible Party
Dr Archya Dasgupta, Principal Investigator, Assistant Professor, Radiation Oncology, Tata Memorial Centre
Study Central Contact
Contact: Archya Dasgupta, 2224177000, [email protected]
No location data.