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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
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
University of Florida

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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
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%
1.Primary Outcome
Title Overall Survival
Hide Description Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This multicenter center study was terminated early by mutual decision between the Study Chair/IDE Sponsor and Novocure; therefore, statistical analysis of the 1 participant in the intervention arm was not done.
Arm/Group Title Astrocytoma Patients Control Arm
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame after the start of study treatment for 30 days after the After Treatment Stop Visit
Adverse Event Reporting Description The control arm was a historical control.
 
Arm/Group Title Astrocytoma Patients Control Arm
Hide Arm/Group Description

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
All-Cause Mortality
Astrocytoma Patients Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)      0/0    
Hide Serious Adverse Events
Astrocytoma Patients Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Gastrointestinal disorders     
Vomiting   1/1 (100.00%)  1 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Disease progression  [1]  1/1 (100.00%)  1 0/0  0
Death  [2]  1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
[1]
Inpatient Hospitalization for repeat brain tumor resection
[2]
Disease progression
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Astrocytoma Patients Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Blood and lymphatic system disorders     
Platelet Count Decreased   1/1 (100.00%)  1 0/0  0
Cardiac disorders     
Syncope   1/1 (100.00%)  2 0/0  0
Gastrointestinal disorders     
Nausea   1/1 (100.00%)  1 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
metastatic disease   1/1 (100.00%)  1 0/0  0
Skin and subcutaneous tissue disorders     
Rash   1/1 (100.00%)  1 0/0  0
Reactive Dermatitis   1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
This multicenter center study was terminated early by mutual decision between the Study Chair/IDE Sponsor and Novocure; therefore, statistical analysis of the 1 participant in the intervention arm was not done.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Tran, MD, PhD
Organization: University of Florida
Phone: 352-273-9000
EMail: david.tran@neurosurgery.ufl.edu
Layout table for additonal information
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