Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03607682|
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Small Cell Lung Carcinoma||Procedure: Tumor Treating Fields (TTF) Therapy Device: NovoTTF-200A Device Other: Quality-of-Life Assessment||Not Applicable|
I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.
I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.
IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure.
After completion of study treatment, participants are followed up at 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2022|
|Experimental: Prevention (TTF therapy, NovoTTF-200A device)||
Procedure: Tumor Treating Fields (TTF) Therapy
Undergo TTF therapy
Device: NovoTTF-200A Device
Undergo TTF therapy
Other: Quality-of-Life Assessment
- Percentage of patients continuing therapy until intracranial tumor [ Time Frame: Up to 6 months ]Estimated using Wilson's method and a 95% confidence interval
- Time to intracranial failure [ Time Frame: Up to 3 years ]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.
- Overall survival [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Rate of intracranial failure [ Time Frame: Up to 12 months ]Estimated using the cumulative incidence function
- Rate of decline in cognitive function [ Time Frame: Up to 12 months ]Measured by Hopkins Verbal Language Test
- Time to neurocognitive failure [ Time Frame: Up to 3 years ]Measured by Hopkins Verbal Language Test
- Neurocognitive failure-free survival [ Time Frame: Up to 3 years ]Measured by Hopkins Verbal Language Test
- Evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [ Time Frame: Up to 3 years ]Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
- Incidence of adverse events [ Time Frame: Up to 12 months ]Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607682
|Contact: Clinical Trials Information Programemail@example.com|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Clinical Trials Information Program 800-811-8480 firstname.lastname@example.org|
|Principal Investigator: Albert Attia, MD|
|Principal Investigator:||Albert Attia, MD||Vanderbilt-Ingram Cancer Center|