Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03995667
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document
* Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC
* LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
* ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
* Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy
* Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment
* No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment
* No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
* Life expectancy of at \>= 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60)
* Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:
* Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
* Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
* Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)
* External medical devices (e.g., insulin pumps) are permitted
* Skull defect (e.g. missing bone with no replacement)
* Shunt
* Bullet fragments
* Evidence of increased intracranial pressure (midline shift \> 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
* Sensitivity to conductive hydrogels
* Pregnant or lactating women
* Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy
* Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03995667
Study Brief:
Protocol Section:
NCT03995667