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 @ 4:06 PM
Ignite Modification Date:
2025-12-24 @ 4:06 PM
NCT ID:
NCT01242566
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed supratentorial glioblastoma
* Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
* Patients aged 70 years or older
* KPS above 30 and below 70
* Life expectancy higher than 4 weeks
* Clinical examination at baseline
* Affiliation to Social Security or mandatory beneficiary
* Patient being informed and obtention of written informed consent
Exclusion Criteria:
* Prior surgical resection dated more than 1 month before inclusion
* Prior brain radiotherapy or chemotherapy
* Severe underlying disease which could interfere with survival
* History of hypersensibility reaction on temozolomide components
* Severe bone marrow hypoplasia
* Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
* Absolute neutrophil count \< 1.5x109 cells per liter
* Platelet count \< 100x109 cells per liter
* Hemoglobin \< 9 g/dl
* Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01242566
Study Brief:
Protocol Section:
NCT01242566