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. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Astrocytoma, Grade II Astrocytoma, Grade III |
Intervention |
Combination Product: TTFields with adjuvant temozolomide |
Enrollment | 1 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Astrocytoma Patients | Control Arm |
---|---|---|
![]() |
Patients newly diagnosed with Grade II and III astrocytoma. 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. |
Data collection from medical record only |
Period Title: Overall Study | ||
Started | 1 | 0 |
Completed | 1 | 0 |
Not Completed | 0 | 0 |
Arm/Group Title | Astrocytoma Patients | Control Arm | Total | |
---|---|---|---|---|
![]() |
Patients newly diagnosed with Grade II and III astrocytoma. 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. |
Data collection from medical record only | Total of all reporting groups | |
Overall Number of Baseline Participants | 1 | 0 | 1 | |
![]() |
No subjects were enrolled in the control arm.
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1 participants | 0 participants | 1 participants | |
<=18 years |
0 0.0%
|
0 |
0 0.0%
|
|
Between 18 and 65 years |
1 100.0%
|
0 |
1 100.0%
|
|
>=65 years |
0 0.0%
|
0 |
0 0.0%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1 participants | 0 participants | 1 participants | |
Female |
0 0.0%
|
0 |
0 0.0%
|
|
Male |
1 100.0%
|
0 |
1 100.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1 participants | 0 participants | 1 participants | |
Hispanic or Latino |
0 0.0%
|
0 |
0 0.0%
|
|
Not Hispanic or Latino |
1 100.0%
|
0 |
1 100.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 |
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1 participants | 0 participants | 1 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 |
0 0.0%
|
|
Asian |
0 0.0%
|
0 |
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 |
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 |
0 0.0%
|
|
White |
1 100.0%
|
0 |
1 100.0%
|
|
More than one race |
0 0.0%
|
0 |
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 |
0 0.0%
|
Name/Title: | David Tran, MD, PhD |
Organization: | University of Florida |
Phone: | 352-273-9000 |
EMail: | david.tran@neurosurgery.ufl.edu |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT03906448 |
Other Study ID Numbers: |
IRB201800600 OCR17711 ( Other Identifier: UF OnCore ) |
First Submitted: | April 4, 2019 |
First Posted: | April 8, 2019 |
Results First Submitted: | August 26, 2021 |
Results First Posted: | September 23, 2021 |
Last Update Posted: | September 23, 2021 |