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Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) – Phase I/II Trial

Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Glioblastoma Multiforme

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Trial Information

Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) – Phase I/II Trial

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)


- Pregnant or lactating women

- Participation in another clinical study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Daniela Schulz-Ertner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Cetuximab
  • Glioblastoma