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|NCT03232424 : NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
1. Histologically confirmed GBM using WHO criteria.
2. Age = 18 years
3. Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not
4. KPS = 70
5. Life expectancy of at least 3 months.
6. Sexually active participants must agree to the strict use of barrier contraception.
7. Patients must be able to understand the investigational nature of the study and
provide informed consent.
8. Adequate hematologic function:
1. Absolute neutrophil count (ANC) = 1.5 x 109/L
2. Platelet count ) = 100 x 109/L
3. Hemoglobin = 10 g /dL
9. Adequate liver function
1. Total bilirubin = 1.5 x ULN
2. AST and ALT = 2.5 x ULN
10. Adequate renal function
a. Creatinine = 1.25 x ULN
11. International normalized ratio (INR) or PT and activated partial thromboplastin time
(aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of
anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits
(according to the medical standard of the institution).
1. Active participation in another clinical treatment trial. Concomitant protocols for
data or tissue collection without intervention are permitted.
2. Any prior treatment for GBM aside from surgery, including carmustine wafers.
3. Women who are pregnant or nursing.
4. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that could increase the risk associated with trial participation, NovoTTF-200A device
use or interfere with interpretation of trial results and, in the judgment of the
investigator, would make the patient inappropriate for entry into the trial. This
includes but not limited to:
1. Patients with inadequately healed surgical incisions or other dermatologic scalp
toxicity at baseline (grade 2 or higher, as defined in Section VIII) upon which
transducer leads may require placement.
2. Known HIV or other immunosuppressive disease, chronic hepatitis B or hepatitis C
3. Dementia or significantly altered mental status that would prohibit the
understanding or rendering of informed consent and compliance with the
requirements of the protocol.
5. Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator,
other implanted electronic devices in the brain or documented clinically significant
6. Infratentorial glioblastoma.
7. Past hypersensitivity reaction to temozolomide or DTIC.
8. Psychiatric illness that compromises the informed consent process, at the discretion
of the investigator.
9. Inability or unwillingness to return for required visits.
10. Previous cytotoxic therapy within the last 5 years.
11. Inability to begin temozolomide concomitant to radiation therapy, for reasons 4 or 7
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03232424
| Link to official Clinicaltrials.gov listing