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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Astrocytoma Patients	Control Arm
Arm/Group Description	Patients newly diagnosed with Grade...	Data collection from medical record...
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

Baseline Characteristics

Arm/Group Title		Astrocytoma Patients	Control Arm	Total
Arm/Group Description		Patients newly diagnosed with Grade...	Data collection from medical record...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Frequency of overall survival in study participants. 2 years of active...
Description	Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
Time Frame	Up to 2 years

Outcome Measure Data

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
Arm/Group Description:	Patients newly diagnosed with Grade...	Data collection from medical record...
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.

Adverse Events

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
Arm/Group Description	Patients newly diagnosed with Grade...		Data collection from medical record...
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
Serious Adverse Events 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
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

Limitations and Caveats

More Information

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

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