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
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Astrocytoma, Grade II Astrocytoma, Grade III||Combination Product: TTFields with adjuvant temozolomide||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 20, 2019|
|Actual Primary Completion Date :||June 8, 2020|
|Actual Study Completion Date :||June 8, 2020|
Experimental: Astrocytoma Patients
Patients newly diagnosed with Grade II and III astrocytoma.
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
No Intervention: Control Arm
Data collection from medical record only
- Overall Survival [ Time Frame: Up to 2 years ]Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
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): NCT03906448
|United States, Florida|
|UF Health at the University of Florida|
|Gainesville, Florida, United States, 32610|
|USF Health Morsani College of Medicine-Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Rhode Island|
|Brown University-Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Texas|
|The University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Study Chair:||David Tran, MD, PhD||University of Florida|