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EF-32 (TRIDENT): A PIVOTAL RANDOMIZED, OPEN-LABEL STUDY OF HEADG2 (TTFIELDS, (200KHZ) CONCOMITANT WITH RADIATION THERAPY AND TEMOZOLOMIDE FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA (TRIDENT)

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

Azuma Hisaya

Novocure K.K.

Kyobashi Edogrand 2-2-1, Kyobashi, Chuo-ku Tokyo 104-0031, Japan

hazuma@novocure.com

Azuma Hisaya

Novocure K.K.

Kyobashi Edogrand 2-2-1, Kyobashi, Chuo-ku Tokyo 104-0031, Japan

+81-3-599-5670

hazuma@novocure.com

Not Recruiting

Sept. 22, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

factorial assignment

treatment purpose

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 x 5 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 voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
9. Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
10. Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
11. Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 14 days prior to registration
12. Is able to have MRI with contrast of the brain

All individuals meeting any of the following exclusion criteria will be excluded from study participation:
1. Progressive disease (per investigator's assessment)
2. Infratentorial or leptomeningeal disease
3. Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
4. Pregnancy or breast feeding
5. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
a. Thrombocytopenia (platelet count less than 100 x 103/maicroL)
b. Neutropenia (absolute neutrophil count less than 1.5 x 103/microL)
c. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
d. Significant liver function impairment (AST or ALT more than 1.7 mg/dL, or more than 150 micro mol/L)
e. Total bilirubin more than 1.5 x upper limit of normal
f. Significant renal impairment (serum creatinine more than 1.7 mg/dL, or more than 150 micro mol/L)
6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
g. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirement of the study or to provide consent
7. Evidence of increased intracranial pressure: midline shift less than 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness (midline shift less than 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
8. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC
9. Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered exclusion
10. Admitted to an institution by administrative or count order
11. Known allergies to medical adhesives or hydrogel
12. A skull defect (such as, missing bone with no replacement)
13. Prior radiation treatment to the brain for the treatment of GBM
14. Any serious surgical/post-operative condition that may risk the patient according to the investigator
15. Standard TTFields exclusion criteria include
a. Active implanted medical devices
b. Bullet fragments
c. Skull defects

Both

Histologically confirmed diagnosis of GBM according to WHO classification criteria

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

Primary: Overall survival (OS)

+81-422-47-5511

Feb. 15, 2022

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Feb. 15, 2022

+81-11-716-1161

Feb. 15, 2022

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Feb. 15, 2022

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Feb. 15, 2022

No

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