Clinical trial · Interventional
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial. Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Radiation therapy | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity
Secondary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 and \< 70 years of age * Karnofsky Performance Score \>= 60 * histologically confirmed supratentorial GBM * interval between primary diagnosis and registration for the study \< 4 weeks * patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3 * adequate blood values (not older than 14 days prior to initiation of RCHT) * neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3 * platelets ≥100.000/mm3 * hemoglobin ≥10g/dL * BUN \<1.5 times the upper range * Total and direct bilirubin \<1.5times the upper laboratory limit * Adequate liver enzymes \<3 times the upper laboratory limit * Life expectancy \>12 weeks * Written informed consent Exclusion Criteria: * refusal of the patients to take part in the study * previous radiotherapy of the brain or chemotherapy with DTIC or TMZ * known allergy against extrinsical proteins * previous chemotherapy or therapy with an EGFR-inhibitor * Previous antibody therapy * Patients who have not yet recovered from acute toxicities of prior therapies * Acute infections requiring systemic application of antibiotics * Frequent vomiting or a medical condition preventing the oral application of TMZ * Clinically active kidney- liver or cardiac disease * Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) * HIV * Pregnant or lactating women * Participation in another clinical study
References
Publications (0)
Data not yet available