Trial Outcomes & Findings for FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma (NCT NCT03906448)
NCT ID: NCT03906448
Last Updated: 2021-09-23
Results Overview
Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-09-23
Participant Flow
Participant milestones
| Measure |
Astrocytoma Patients
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.
|
Control Arm
Data collection from medical record only
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma
Baseline characteristics by cohort
| Measure |
Astrocytoma Patients
n=1 Participants
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.
|
Control Arm
Data collection from medical record only
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
Frequency of overall survival in study participants. 2 years of active treatment, lifelong survival follow-up.
Outcome measures
Outcome data not reported
Adverse Events
Astrocytoma Patients
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Astrocytoma Patients
n=1 participants at risk
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.
|
Control Arm
Data collection from medical record only
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
Other adverse events
| Measure |
Astrocytoma Patients
n=1 participants at risk
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.
|
Control Arm
Data collection from medical record only
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Cardiac disorders
Syncope
|
100.0%
1/1 • Number of events 2 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Skin and subcutaneous tissue disorders
Reactive Dermatitis
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic disease
|
100.0%
1/1 • Number of events 1 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
—
0/0 • after the start of study treatment for 30 days after the After Treatment Stop Visit
The control arm was a historical control.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place