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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT01873469
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed newly diagnosed glioblastoma multiforme
* macroscopic total tumour resection or biopsy
* indication for combined radiochemotherapy with temozolomide
* patients are allowed to take part in other clinical trials at the same time
* beginning of radiochemotherapy no later than 7 weeks after surgery
* Karnofsky Performance Score ≥ 60, ECOG ≤2
* women with childbearing potential, (and men) adequate contraception
* ability of subject to understand character and individual consequences of the clinical trial
* written informed consent
Exclusion Criteria:
* previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy
* time interval of \> 7 weeks after surgery and beginning of radiochemotherapy
* patients who are not suitable for radiochemotherapy
* known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy
* pregnant or lactating women
* patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators, insulin pumps, neurostimulators, cochlear implants
* Claustrophobic patients
* refusal of the patients to take part in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01873469
Study Brief:
Protocol Section:
NCT01873469