Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00311857
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00311857
Study Brief:
Protocol Section:
NCT00311857