Clinical trial · Interventional
NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer
NovoTTFTM-100A System Therapy for Refractory CNS Involved Small Cell Lung Cancer
NCT02425072CI-TRIAL-00029030withdrawnPhase 2ClinicalTrials.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): slow accrual
Summary
Brief summary (as posted)
The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NovoTTF-100A plus chemotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NovoTTF-100A plus chemotherapy
- description
- NovoTTF-100A System with Physician's Choice Chemotherapy
- interventionNames
- Device: NovoTTF-100A plus chemotherapy
Primary outcomes (1)
- measure
- Time to treatment failure
- timeFrame
- Up to 3 months
Secondary outcomes (4)
- measure
- Progression Free Survival
- timeFrame
- Up to 6 months
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed small cell lung cancer histology with CNS metastases * Parenchymal disease, ten or less lesions, and supratentorial * PS 70% or greater * Prior CNS radiotherapy. * No previous or currently active second malignancy * Age \> 22 years. * Life expectancy of ≥ 3 months. Exclusion Criteria: * Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal; Total bilirubin \> upper limit of normal. * Significant renal impairment (serum creatinine \> 1.7 mg/dL). * Coagulopathy (as evidenced by PT or APTT \>1.5 times in control patients not undergoing anticoagulation).Thrombocytopenia (platelet count \< 100 x 103/μL). * Neutropenia (absolute neutrophil count \< 1 x 103/μL). * Anemia (Hb \< 10 g/L). * Severe acute infection. Serious non-healing wound or ulcer on scalp * Significant co-morbidities within 4 weeks prior to enrollment. * 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). * Skull defect (e.g. missing bone with no replacement). * Shunt * Bullet fragments * Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness). * Sensitivity to conductive hydrogels. * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.