Trial Outcomes & Findings for Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain (NCT NCT03488472)
NCT ID: NCT03488472
Last Updated: 2023-05-06
Results Overview
Rate of distant CNS metastases/progression will be calculated as the total number of patients with such events divided by the total number of patients.
TERMINATED
NA
1 participants
From date of first SRS treatment to time of the 6 month follow-up MRI
2023-05-06
Participant Flow
Participant milestones
| Measure |
NovoTTF-200A Device + Stereotactic Radiosurgery (SRS)
Patients will undergo SRS treatment followed by continuous TTFields by wearing the NovoTTF-200A device over 18 hours QD. Treatment continues for up to 1 year or until progression.
NovoTTF-200A: Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.
Stereotactic Radiosurgery (SRS): SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
NovoTTF-200A Device + Stereotactic Radiosurgery (SRS)
Patients will undergo SRS treatment followed by continuous TTFields by wearing the NovoTTF-200A device over 18 hours QD. Treatment continues for up to 1 year or until progression.
NovoTTF-200A: Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.
Stereotactic Radiosurgery (SRS): SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.
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|---|---|
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Overall Study
disease progression additional mets
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1
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Baseline Characteristics
Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
Baseline characteristics by cohort
| Measure |
NovoTTF-200A Device + Stereotactic Radiosurgery (SRS)
n=1 Participants
Patients will undergo SRS treatment followed by continuous TTFields by wearing the NovoTTF-200A device over 18 hours QD. Treatment continues for up to 1 year or until progression.
NovoTTF-200A: Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.
Stereotactic Radiosurgery (SRS): SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From date of first SRS treatment to time of the 6 month follow-up MRIPopulation: The 1 patient enrolled started treatment but was discontinued due adrenal mets. Therefore, data not collected.
Rate of distant CNS metastases/progression will be calculated as the total number of patients with such events divided by the total number of patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.Population: The 1 patient enrolled started treatment but was discontinued due adrenal mets. Therefore, data not collected.
Overall survival will be measured as time from first SRS treatment to date of death, or censored as the last follow-up, whichever comes first. Overall survival rates will be analyzed using the Kaplan-Meier (KM) method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.Population: The 1 patient enrolled started treatment but was discontinued due adrenal mets. Therefore, data not collected.
Local recurrence will be defined as a measurable lesion deemed likely to be a brain metastases found within the treated area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.Population: The 1 patient enrolled started treatment but was discontinued due adrenal mets. Therefore, data not collected.
Distant CNS Progression is defined as development of new metastases outside the treated area.
Outcome measures
Outcome data not reported
Adverse Events
NovoTTF-200A Device + Stereotactic Radiosurgery (SRS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Drexell Hunter Boggs, MD; Principal Investigator
University of Alabama at Birmingham (UAB)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place