Combined Radiochemotherapy with Erbitux (Cetuximab) plus Temozolomide in the primary therapy of Glioblastoma Multiforme (GBM) - Phase I/II Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003911-63-DE

Enrollment

Registered

2005-10-26

Start date

2006-01-12

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme (GBM)

Interventions

Product Name: Erbitux (Cetuximab) Product Code: EMD271786 Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed Glioblastoma Multiforme (GBM) Age >=18 Age =60 Adequate blood values Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous Radiotherapy to the brain or chemotherapy with temozolomide Previous therapy with an EGFR-inhibitor Previous therapy with antibodies

Design outcomes

Primary

Measure	Time frame
Main Objective: Toxicity and feasibility;Secondary Objective: Progression-free survival Overall Survival Quality of Life;Primary end point(s): toxicity	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026