FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma (FORWARD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03906448|
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : November 15, 2019
|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 II 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|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2024|
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
- 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
|Contact: Annie Allenfirstname.lastname@example.org|
|United States, Florida|
|UF Health at the University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Annie Allen 352-294-8836 email@example.com|
|Principal Investigator: Ashley Ghiaseddin, MD|
|United States, Michigan|
|Henry Ford Health System||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Ken Winters, R.N., OCN 313-916-1049 firstname.lastname@example.org|
|Principal Investigator: James Snyder, D.O.|
|Study Chair:||David Tran, MD, PhD||University of Florida|