Brain MetastasesRAD 1704NCT03488472
Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
A study testing NovoTTF-200A and Stereotactic Radiosurgery (SRS) in people with Brain Metastases and Small Cell Lung Cancer, run by Drexell Hunter Boggs at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Metastases, Small Cell Lung Cancer
- What is being tested?
- NovoTTF-200A and Stereotactic Radiosurgery (SRS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham (UAB), Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham, Alabama, 35233
About this study
Official title: 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)
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).
Read the detailed description
Tumor Treating Fields (TTFields) are low intensity alternating electric fields, which are tuned to interfere with the division process of cancer cells. TTFields are delivered to the region of cancer using an investigational device, called the NovoTTF-200A system. The device is portable, light weighted, battery operated device designed to deliver TTFields to brain metastases from small cell lung cancer (SCLC).
TTFields are a novel, non-invasive regional anti-mitotic treatment modality. Pre-clinical studies and clinical data in glioblastoma multiforme (GBM) have demonstrated a favorable safety profile and clinical superiority when treating the brain with TTFields. In addition, durable response have been demonstrated with 200kHz TTFields monotherapy for supratentorial tumors of the brain.
The development of brain metastases is devastating for SCLC patients and their families. Treatment options in this setting are limited to SRS or WBRT or a combination thereof. Few clinicians treat SCLC brain metastases with SRS alone because intracranial recurrence is high due to the fact that the entire brain is not treated. WBRT treats the entire brain and improves intracranial control, but at the risk of neurocognitive complications. Thus, new therapeutic options are needed, particularly ones that allow for greater intracranial control while minimizing the risk of neurocognitive adverse events. As such, TTFields following SRS may allow for sufficient regional treatment of the brain to eliminate any remaining tumor cells following radiosurgery as well as micro-metastases that remain untreated, and ultimately prolong intracranial control. Due to the favorable safety profile seen in phase III recurrent and newly diagnosed glioblastoma trials and in which the patients reported improved neurocognitive and emotional functioning, NovoTTF-200A is not expected to have neuro-toxic effects seen with WBRT.
Thus, the investigators hypothesize that the use of NovoTTF-200A applied to the brain following SRS for SCLC brain metastases will have cerebral control comparable to WBRT with less neurocognitive effects.
The patient will undergo stereotactic radiosurgery (SRS). Radiosurgery is a single treatment and will be done as an outpatient procedure.
Stereotactic Radiosurgery (SRS) will be followed by continuous TTFields treatment using the NovoTTF-200A. The patient will start using the NovoTTF-200A device within 7 days of SRS. The NovoTTF-200A treatment will be started by the device support specialist (DSS), trained by NovoCure, or by your study doctor. The patient will be educated and trained on how to properly use the device in the clinic or by a separately scheduled home visit. During this visit, the patient will be told how to operate the device, replace depleted batteries, recharge them, and connect to an external power supply. All patients will be required to shave their head, so the transducer arrays can be placed. Patients will wear 4 electronically insulated transducer arrays (sticky pads) on the top of the patient's head (based on the patient's tumor location) for the time the patient is using the device.
After this visit, the patient will continue treatment at home where participants can maintain regular daily routine. The patient must use the device for at least 18 hours a day per day on average. Breaks are allowed for personal needs (e.g. showering/bathing, array exchange). Patients will be instructed to replace the Transducer arrays 2-3 times a week with help of a caregiver. Patients will be instructed to use the device for a minimum of 4 weeks from the time of initiation. The NovoTTF-200A device will be inspected, either by the study doctor, research nurse, or by a Novocure representative, on a monthly basis to assess the patient's compliance with treatment. Each course of using the device will consist of continuous NovoTTF-200A use for one month. Multiple courses will be offered as long as the patient's tumor(s) in the brain have not come back. If the patient's tumor(s) do come back, the patient will need to terminate use of NovoTTF-200A. If tumors do not return in the patient's brain, the patient will be able to stay on NovoTTF-200A for up to 1 year.
Patients will be asked to visit the study doctor for follow-up care at several monthly intervals (1, 3, 6, 9, an 12 months after completion of stereotactic radiosurgery), or until the tumor(s) in the patient's brain return.
- Conditions
- Brain Metastases, Small Cell Lung Cancer
- Being tested
- NovoTTF-200A, Stereotactic Radiosurgery (SRS)
- Medical subject headings
- Brain Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-200ADevice
Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.
Stereotactic Radiosurgery (SRS)Radiation
SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF-200A device + Stereotactic Radiosurgery (SRS) | Experimental | 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. Receives: Device: NovoTTF-200A; Radiation: Stereotactic Radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Distant Metastases
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.
Measured: From date of first SRS treatment to time of the 6 month follow-up MRI
Secondary outcomes (3)
Overall Survival
Overall survival will be measured as time from first SRS treatment to date of death, or censored as the last follow-up, whichever comes first. Overall survival rates will be analyzed using the Kaplan-Meier (KM) method.
Measured: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Local Recurrence
Local recurrence will be defined as a measurable lesion deemed likely to be a brain metastases found within the treated area.
Measured: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Distant CNS Progression
Distant CNS Progression is defined as development of new metastases outside the treated area.
Measured: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 Aug 2019
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexell Hunter Boggs
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor-investigator, Drexell Hunter Boggs, University of Alabama at Birmingham
- Investigators
- Drexell H Boggs, MD, Principal investigator, University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488472
- Sponsor's protocol ID
- IRB-300001201
- Acronym
- RAD 1704
- Status last verified
- May 2023
- First submitted
- 28 Mar 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03488472
- Acronym / sponsor ID
- RAD 1704 / IRB-300001201
- Conditions
- Brain Metastases, Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Drexell Hunter BoggsUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 4 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Tumor Treating Fields (TTFields) are low intensity alternating electric fields, which are tuned to interfere with the division process of cancer cells. TTFields are delivered to the region of cancer using an investigational device, called the NovoTTF-200A system. The device is portable, light weighted, battery operated device designed to deliver TTFields to brain metastases from small cell lung cancer (SCLC).
TTFields are a novel, non-invasive regional anti-mitotic treatment modality. Pre-clinical studies and clinical data in glioblastoma multiforme (GBM) have demonstrated a favorable safety profile and clinical superiority when treating the brain with TTFields. In addition, durable response have been demonstrated with 200kHz TTFields monotherapy for supratentorial tumors of the brain.
The development of brain metastases is devastating for SCLC patients and their families. Treatment options in this setting are limited to SRS or WBRT or a combination thereof. Few clinicians treat SCLC brain metastases with SRS alone because intracranial recurrence is high due to the fact that the entire brain is not treated. WBRT treats the entire brain and improves intracranial control, but at the risk of neurocognitive complications. Thus, new therapeutic options are needed, particularly ones that allow for greater intracranial control while minimizing the risk of neurocognitive adverse events. As such, TTFields following SRS may allow for sufficient regional treatment of the brain to eliminate any remaining tumor cells following radiosurgery as well as micro-metastases that remain untreated, and ultimately prolong intracranial control. Due to the favorable safety profile seen in phase III recurrent and newly diagnosed glioblastoma trials and in which the patients reported improved neurocognitive and emotional functioning, NovoTTF-200A is not expected to have neuro-toxic effects seen with WBRT.
Thus, the investigators hypothesize that the use of NovoTTF-200A applied to the brain following SRS for SCLC brain metastases will have cerebral control comparable to WBRT with less neurocognitive effects.
The patient will undergo stereotactic radiosurgery (SRS). Radiosurgery is a single treatment and will be done as an outpatient procedure.
Stereotactic Radiosurgery (SRS) will be followed by continuous TTFields treatment using the NovoTTF-200A. The patient will start using the NovoTTF-200A device within 7 days of SRS. The NovoTTF-200A treatment will be started by the device support specialist (DSS), trained by NovoCure, or by your study doctor. The patient will be educated and trained on how to properly use the device in the clinic or by a separately scheduled home visit. During this visit, the patient will be told how to operate the device, replace depleted batteries, recharge them, and connect to an external power supply. All patients will be required to shave their head, so the transducer arrays can be placed. Patients will wear 4 electronically insulated transducer arrays (sticky pads) on the top of the patient's head (based on the patient's tumor location) for the time the patient is using the device.
After this visit, the patient will continue treatment at home where participants can maintain regular daily routine. The patient must use the device for at least 18 hours a day per day on average. Breaks are allowed for personal needs (e.g. showering/bathing, array exchange). Patients will be instructed to replace the Transducer arrays 2-3 times a week with help of a caregiver. Patients will be instructed to use the device for a minimum of 4 weeks from the time of initiation. The NovoTTF-200A device will be inspected, either by the study doctor, research nurse, or by a Novocure representative, on a monthly basis to assess the patient's compliance with treatment. Each course of using the device will consist of continuous NovoTTF-200A use for one month. Multiple courses will be offered as long as the patient's tumor(s) in the brain have not come back. If the patient's tumor(s) do come back, the patient will need to terminate use of NovoTTF-200A. If tumors do not return in the patient's brain, the patient will be able to stay on NovoTTF-200A for up to 1 year.
Patients will be asked to visit the study doctor for follow-up care at several monthly intervals (1, 3, 6, 9, an 12 months after completion of stereotactic radiosurgery), or until the tumor(s) in the patient's brain return.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoTTF-200A device + Stereotactic Radiosurgery (SRS) | Experimental | Device: NovoTTF-200A, Radiation: Stereotactic Radiosurgery (SRS)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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-200ABegins within 7 days of SRS and continues until progression, death, or unacceptable toxicity. | Device | NovoTTF-200A device + Stereotactic Radiosurgery (SRS) |
| Stereotactic Radiosurgery (SRS)SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy. | Radiation | NovoTTF-200A device + Stereotactic Radiosurgery (SRS) |
Primary outcome
Rate of Distant Metastases
Time frame: From date of first SRS treatment to time of the 6 month follow-up MRI
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.
3 secondary outcomes
Overall Survival
Time frame: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Local Recurrence
Time frame: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Distant CNS Progression
Time frame: From time of first SRS treatment to date of death, or censored as the last follow-up, whichever comes first, for up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drexell H Boggs, MD principal investigator
University of Alabama at Birmingham (UAB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovoTTF-200A and Stereotactic Radiosurgery (SRS) in people with Brain Metastases and Small Cell Lung Cancer, run by Drexell Hunter Boggs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Distant Metastases (time frame: From date of first SRS treatment to time of the 6 month follow-up MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.