FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma (FORWARD)
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ClinicalTrials.gov Identifier: NCT03906448 |
Recruitment Status :
Terminated
(The study was terminated because the Study Chair/IDE Sponsor and Novocure determined that conducting this trial was not feasible without CMS approval.)
First Posted : April 8, 2019
Results First Posted : September 23, 2021
Last Update Posted : September 23, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | April 4, 2019 | ||||
First Posted Date ICMJE | April 8, 2019 | ||||
Results First Submitted Date ICMJE | August 26, 2021 | ||||
Results First Posted Date ICMJE | September 23, 2021 | ||||
Last Update Posted Date | September 23, 2021 | ||||
Actual Study Start Date ICMJE | May 20, 2019 | ||||
Actual Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Up to 2 years ] Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma | ||||
Official Title ICMJE | A Phase 2, Historically Controlled Study Testing the Efficacy of TTFields (Optune®) With Adjuvant Temozolomide in High Risk WHO Grade II and III Astrocytomas (FORWARD) | ||||
Brief Summary | This is a phase 2, multi-institutional, historically-controlled, study of 100 patients with newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with adjuvant temozolomide versus temozolomide alone in historical controls after the completion of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence. The primary endpoint will be overall survival. | ||||
Detailed Description | Patients with newly diagnosed high-risk Grade II or III astrocytoma must undergo maximal safe resection (biopsy alone may be eligible) and chemoradiotherapy: concomitant 75mg/m2 daily temozolomide with 80% prescribed dose completed and RT with minimal RT dose of 40 Gy delivered. Within three weeks prior to beginning adjuvant temozolomide, all patients will undergo a Baseline contrast-enhanced MRI of the brain. Within two weeks prior to beginning adjuvant temozolomide, all patients will undergo baseline assessments. Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given. Patients will be seen and examined before each cycle of temozolomide. After a maximum of 12 cycles of adjuvant temozolomide, patients will be seen every 8 weeks. Brain MRI and QoL assessments will be performed every 8 weeks following the baseline MRI for the first 2 years then every 3 months thereafter until second progression (when TTFields treatment will be terminated). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Combination Product: TTFields with adjuvant temozolomide
Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity.
Other Name: Optune
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
1 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | June 8, 2020 | ||||
Actual Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03906448 | ||||
Other Study ID Numbers ICMJE | IRB201800600 OCR17711 ( Other Identifier: UF OnCore ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Florida | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Florida | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | NovoCure Ltd. | ||||
Investigators ICMJE |
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PRS Account | University of Florida | ||||
Verification Date | August 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |