Trial Outcomes & Findings for Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer (NCT NCT03607682)
NCT ID: NCT03607682
Last Updated: 2020-08-04
Results Overview
Count of patients developed intracranial tumor divided by total number of patients.
TERMINATED
NA
2 participants
Up to 6 months
2020-08-04
Participant Flow
This trial was open to accrual from September 2018 to June 2020 at Vanderbilt Medical Center in Nashville, TN. Two participants were enrolled. The study stopped early due to loss of funding.
2 participants were enrolled; 1 participant had disease progression and was not on the study long enough to be evaluable.
Participant milestones
| Measure |
Prevention (TTF Therapy, NovoTTF-200A Device)
Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Prevention (TTF Therapy, NovoTTF-200A Device)
Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Prevention (TTF Therapy, NovoTTF-200A Device)
n=2 Participants
Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
|
Age, Categorical
Race · <=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Race · Between 18 and 65 years
|
1 Participants
n=39 Participants
|
|
Age, Categorical
Race · >=65 years
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: patients on the therapy
Count of patients developed intracranial tumor divided by total number of patients.
Outcome measures
| Measure |
Prevention (TTF Therapy, NovoTTF-200A Device)
n=2 Participants
Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Percentage of Patients Continuing Therapy Until Intracranial Tumor
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected do to loss of funding.
Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected do to loss of funding.
Estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data was not collected do to loss of funding.
Estimated using the cumulative incidence function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data was not collected do to loss of funding.
Measured by Hopkins Verbal Language Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected do to loss of funding.
Measured by Hopkins Verbal Language Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected do to loss of funding.
Measured by Hopkins Verbal Language Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data was not collected do to loss of funding.
Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Patients on the therapy
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Prevention (TTF Therapy, NovoTTF-200A Device)
n=2 Participants
Tumor Treating Fields (TTF) Therapy: Undergo TTF therapy
NovoTTF-200A Device: Undergo TTF therapy
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Incidence of Adverse Events
|
0 Participants
|
Adverse Events
Prevention (TTF Therapy, NovoTTF-200A Device)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place