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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT03780569
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.
2. Supratentorial tumor location
3. Age ≥ 18 years
4. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
5. Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m\^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.
6. Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m\^2 daily x 5 d, q28 days)
7. Karnofsky performance status ≥ 70
8. Life expectancy ≥ 3 months
9. Participants of childbearing age must use effective contraception.
10. All patients must sign written informed consent.
11. NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
12. NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
13. Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.
Exclusion Criteria:
1. Participation in another clinical treatment trial
2. Pregnancy or breast feeding
3. Significant co-morbidities at baseline which would preclude TMZ treatment
4. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
5. Infra-tentorial tumor location
6. Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
7. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
8. Known allergies to medical adhesives or gel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03780569
Study Brief:
Protocol Section:
NCT03780569