A PIVOTAL RANDOMIZED, OPEN-LABEL PHASE 3 STUDY OF HEADG2

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2022
INTERVENTION: A PIVOTAL RANDOMIZED, OPEN‐LABEL STUDY Name of study device for evaluation:HeadG2 system Intervention duration:24 months after randomization Contents of intervention: Study Arm:TTField(200 kHz 18 hours/day) + Radiation Therapy + temozolomide 6 weeks as maintenance for TTField(200 kHz 18 hours/day) + temozolomide 6 course Control Arm:Radiation Therapy + temozolomide 6 weeks as maintenance for TTField(200 kHz 18 hours/day) + temozolomide 6 course Test: Physical examination:heart rate, blood pressure, respiration rate, body temparature, weight, height, Examination and review of the following systems:head and neck, cardiac, pulmonary, abdominal, extremities, skin. neurological Blood test, Blood Chemistry, Coagulation MRI scan CONDITION: Histologically confirmed diagnosis of GBM according to WHO classification criteria PRIMARY OUTCOME: Primary: Overall survival (OS) INCLUSION CRITERIA: Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Histologically confirmed diagnosis of GBM according to WHO classification criteria. 2. Age more than equal 18 years 3. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy‐only patients are all acceptable) 4. Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ with 150‐200 mg/m2 daily X5 d, q28 days 5. Karnofsky performance status more than equal 70 6. Life expectancy more than least 3 months 7. Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed. 8. All patients must understand and
Epistemonikos ID: 480d9d092e486b0f5ca1d9953f08150b18ba26c7
First added on: Aug 26, 2024