Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
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ClinicalTrials.gov Identifier: NCT00916409 |
Recruitment Status :
Completed
First Posted : June 9, 2009
Last Update Posted : April 10, 2017
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Multiforme | Device: NovoTTF-100A device Drug: Temozolomide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM. |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | March 2017 |
Arm | Intervention/treatment |
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Experimental: NovoTTF-100A device in combination with Temozolomide
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
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Device: NovoTTF-100A device
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. |
Active Comparator: Temozolomide alone, as the best known standard of care
Patients will be treated with Temozolomide, as the best known standard of care for Glioblastoma Multiforme patients.
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Drug: Temozolomide
maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. Cycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. |
- Progression Free Survival (PFS) time [ Time Frame: 5 years ]
- Overall survival (OS) [ Time Frame: 5 years ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathological evidence of GBM using WHO classification criteria.
- > 18 years of age.
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Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):
- Patients may enroll in the study if received Gliadel wafers before entering the trial
- Any additional treatments received prior to enrollment will be considered an exclusion.
- Minimal dose for concomitant radiotherapy is 45 Gy
- Karnofsky scale ≥ 70
- Life expectancy at least 3 months
- Participants of childbearing age must use effective contraception.
- All patients must sign written informed consent.
- Treatment start date at least 4 weeks out from surgery.
- Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.
Exclusion Criteria:
- Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- Actively participating in another clinical treatment trial
- Pregnant
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Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- Thrombocytopenia (platelet count < 100 x 103/μL)
- Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
- Total bilirubin > upper limit of normal
- Significant renal impairment (serum creatinine > 1.7 mg/dL)
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Infra-tentorial tumor
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916409
Study Director: | Roger Stupp, MD | University Hospital, Zürich | |
Study Director: | Philip H. Gutin, MD | Memorial Sloan Kettering Cancer Center | |
Study Director: | Eric T. Wong, MD | Beth Israel Deaconess Medical Center | |
Study Director: | Herbert H. Engelhard, MD, PhD | University of Illinois at Chicago | |
Study Director: | Manfred Westphal, Prof. MD | Universitätsklinikum Hamburg-Eppendorf |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | NovoCure Ltd. |
ClinicalTrials.gov Identifier: | NCT00916409 |
Other Study ID Numbers: |
EF-14 |
First Posted: | June 9, 2009 Key Record Dates |
Last Update Posted: | April 10, 2017 |
Last Verified: | April 2017 |
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