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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
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The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.
To study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA NSCLC.
Participants in this study will have a blood sample collected as well as vital signs along with a tumor tissue sample and tumor scan. Once it has been determined the participant can enroll into this study, he/she will come to the clinic for 5 scheduled visits over a period of 2 months .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Treatment Fields | Experimental | Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery. Cycle Length: 2-4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoTTF-200T System | Device | Exposure/Frequency: 150 kHz Route: Transdermal through patented microarray system to the hemithorax affected with cancer, 2-4 week duration, target 18 hours/day (on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes. | Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC. | approximately 14-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of administering TTFields | Assess the safety of administering TTFields prior to standard of care lung cancer resection. Analyses will be performed for all subjects having initiated TTFields therapy. The study will use the CTCAE version 5.0 for reporting of adverse events. | approximately 14-28 days |
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Inclusion Criteria:
Diagnosis of stage I-IIIA NSCLC planned for surgical resection.
Eastern Cooperative Oncology Group (ECOG) 0-2 performance status.
Willingness and ability to undergo planned correlative studies, including imaging tests.
Fresh biopsy diagnostic material obtained from standard of care procedure to perform baseline correlatives (10-15 slides)-if not available, enrollment will be considered on a case-by-case basis after discussion with and approval by the Lead Site PI or Lead Site Co-Principal Investigator.
Ability to understand and the willingness to sign a written informed consent.
All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Age ≥22 years at time of screening.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebele Mbanugo, Ed.D, CCRP | Contact | 214-645-0326 | ebele.mbanugo@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Waters, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |