Temozolomide for Glioblastoma | Glioblastoma multiforme

Inclusion criteria

• {"criterion_text":"-Patient ≥18 years old\n-planned MGMT analysis (results not mandatory at inclusion but must be further reported in the eCRF)\n-Written informed consent from patient or the person of trust (“personne de confiance”)\n-France and Belgium: Patient covered by the French or Belgian “Social Security” regime\n-Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.\n-Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 14 days (ideally in the first 7 days)\n-Karnofsky performance status (KPS) ≥ 60%, or KPS <60% only related to glioma-related motor paresis.\n-Adequate biological functions: neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3 independent of transfusion, serum creatinine ≤ 1.5 times ULN; transaminases (ALAT/ ASAT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN (except in case of Gilbert’s disease)\n-Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)\n-Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.\n-Standard radiation therapy deemed feasible (60 Gy, 30 fractions)\n-Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy"}

Exclusion criteria

• {"criterion_text":"-IDH-mutant (IDH1 ou IDH2) astrocytoma (grade 4) or recurrent gliosblastoma (GBM)\n-Planned use of Carmustine implants\n-Prior malignancy in the last 5 years before inclusion or concomitant\n-Severe myelosuppression\n-Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)\n-Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion)\n-Known current viral hepatitis, HIV infection or current active infectious disease\n-Inability to swallow oral medications or any mal-absorption condition\n-Pregnant or breastfeeding patients.\n-Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)\n-Person under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"-Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news.","definition_or_measurement_approach":"Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news."}

Secondary endpoints

• {"endpoint_text":"-Adverse events occurring from randomization until disease progression will be reported and graded using the NCI-CTCAE v5.0 classification, including those related to the underlying disease or its progression. All AE will be analyzed, and described according to the reported causal relationship. An AE will be classified as Severe AE if grade is equal or higher than 3 for extra-hematological AE and grade 4 for hematological AE.","definition_or_measurement_approach":"Reported from randomization until disease progression, graded using NCI-CTCAE v5.0; severe AE defined as grade ≥3 for extra-hematological AE and grade 4 for hematological AE."}
• {"endpoint_text":"-Progression-free survival will be defined as time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause. Patients alive without progressive disease will be censored at the date of last news. There will be no central radiological review. The type of progression will be collected (local or peri-local, remotely in the brain, remotely in the meninges)","definition_or_measurement_approach":"PFS defined as time from randomization to first progression per RANO criteria assessed by treating physician or death; censoring at last contact; no central radiological review; type of progression collected."}
• {"endpoint_text":"-Q-TWiST: Quality-adjusted time without symptoms of disease or adverse event","definition_or_measurement_approach":"Q-TWiST analysis measuring quality-adjusted time without symptoms or severe adverse events."}
• {"endpoint_text":"-Exploratory endpoints: Treatment doses will be computed for each treatment component (radiotherapy & chemotherapy), and by treatment phase (early TMZ / concomitant TMZ / adjuvant TMZ). Early administration of TMZ is unlikely to result in leucopenia and/or thrombocytopenia, which could prevent or inhibit conventional concomitant standard dose chemoradiotherapy. It could also lead to platelet transfusions or infections. Patients will be notified. The percentage of deliveries of complete chemoradio","definition_or_measurement_approach":"Dose computations for radiotherapy and chemotherapy by treatment phase (early TMZ / concomitant TMZ / adjuvant TMZ); assessment of feasibility and treatment delivery completeness; reporting of related hematological events and complications."}
• {"endpoint_text":"-Total dose of irradiation received and dose-intensity.","definition_or_measurement_approach":"Measurement of cumulative irradiation dose and dose-intensity received by each patient."}
• {"endpoint_text":"-Predictive factors of overall survival: the list of studied factors will be defined later. The methylation of the MGMT promoter is mandatory and will be done in each center. Tumor material will be stored in order to study other biomarkers.","definition_or_measurement_approach":"Exploratory analysis of prognostic/predictive factors for OS; MGMT promoter methylation mandatory; tumor material stored for biomarker studies."}
• {"endpoint_text":"-Description of the post-progression treatments: nature and duration.","definition_or_measurement_approach":"Collection and description of post-progression treatments including type and duration."}

France

Latest Decision Or Authorization Date

19-09-2025

Number Of Sites

19

Number Of Participants

400

Belgium

Latest Decision Or Authorization Date

10-11-2025

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Centre Oscar Lambret

Organisation Type

Pharmaceutical company

Country Of Registered Address

France