Clinical trial · Interventional
Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer
Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer
NCT03995667CI-TRIAL-00070889terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields ("TTFields") within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Lung Small Cell Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Limited Stage Lung Small Cell Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA1 Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA2 Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA3 Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire Administration | Other | — | UNRESOLVED |
| Tumor Treating Fields Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (TTFields therapy, questionnaire)
- description
- Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Questionnaire Administration
- Device: Tumor Treating Fields Therapy
Primary outcomes (1)
- measure
- Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
- timeFrame
- 6 months following start of tumor treating fields (TTFields) therapy
Secondary outcomes (6)
- measure
- Incidence of SCLC Brain Metastases at 12 Months
- timeFrame
- 12 months following start of TTFields therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.