Clinical trial · Interventional
Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
A Pilot and Feasibility Trial to Determine the Rate of the Brain Relapse in Small Cell Lung Cancer (SCLC) Patients With Brain Metastases Treated With Stereotactic Radiosurgery (SRS) Followed by Tumor Treating Fields (TTF)
NCT03488472CI-TRIAL-00066194RAD 1704terminatedN/AResults 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): This feasibility study only accrued one patient since site activation. We believe that the primary reason for this is low patient motivation to go on study and wear the device. We attempted to broaden this study to partner sites without success.
Summary
Brief summary (as posted)
This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).
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 Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NovoTTF-200A | Device | — | UNRESOLVED |
| Stereotactic Radiosurgery (SRS) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NovoTTF-200A device + Stereotactic Radiosurgery (SRS)
- description
- Patients will undergo SRS treatment followed by continuous TTFields by wearing the NovoTTF-200A device over 18 hours QD. Treatment continues for up to 1 year or until progression.
- interventionNames
- Device: NovoTTF-200A
- Radiation: Stereotactic Radiosurgery (SRS)
Primary outcomes (1)
- measure
- Rate of Distant Metastases
- timeFrame
- From date of first SRS treatment to time of the 6 month follow-up MRI
- description
- Rate of distant CNS metastases/progression will be calculated as the total number of patients with such events divided by the total number of patients.
Secondary outcomes (3)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician. * Brain metastases that have not received radiotherapy previously (metastases on post-contrast MRI obtained within six weeks of study entry) deemed to be amenable to SRS. * Longest diameter \< 4 cm * Prior prophylactic cranial irradiation (PCI) is allowed. The maximum allowed dose is 25Gy in 10 fractions. * Prior systemic therapy is allowed after diagnosis of brain metastases provided that restaging MRI shows measurable intracranial disease. * Karnofsky Performance Status (KPS) of greater than or equal to 70. * Age greater than or equal to 18 years. * Life expectancy greater than 3 months. * Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration. * Ability to operate the NovoTTF-200A device independently or with caregiver aid. * Previous clinical trial enrollment is allowed. * Subjects given written informed consent. Exclusion Criteria: * History of prior brain metastases. * Patients with significant edema leading to risk of brain herniation. * History of prior whole brain radiotherapy (WBRT) other than prophylactic cranial radiation. Prophylactic cranial radiation with a maximum dose of 25 Gy delivered as 10 fractions is allowed. WBRT in excess of 25 Gy (anything over 25 Gy) is not allowed. * Diffuse Leptomeningeal metastases with radiographic involvement in the brain and/or spinal cord. This does not include local leptomeningeal involvement which is defined as leptomeningeal enhancement within direct contact of targetable metastases. * Implantable electronic device in the brain. * Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias. * Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness). * Known allergies to medical adhesives or hydrogel. * Currently pregnant or breastfeeding. * Concurrent brain-directed therapy. * Insufficient recovery from all active toxicities of prior therapies. * Women of childbearing potential who are not using an effective method of contraception are excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.