Central Nervous System Neoplasms, PrimaryNCT03530605
Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
A study testing Optune TTF device in people with Central Nervous System Neoplasms, Primary, run by Saint Luke's Health System.
Trial summary
This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Central Nervous System Neoplasms, Primary
- What is being tested?
- Optune TTF device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histological de novo diagnosis of PCNSL
- Tumor located in the supra-tentorial brain region
- Karnofsky performance score of 70 or above
- Ineligible for chemotherapy due to age or other co-morbidities
- Life expectancy of at least 3 months
- Patient has a caretaker willing to assist with study compliance
- Patient is able to provide written consent on their own behalf
Who cannot join
- Second or subsequent recurrence of PCNSL
- Patient wishes to receive systemic treatment
- Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)
- Skull defect without replacement
- Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment
- Patient unable to comply with Optune device treatment or the study follow- up schedule
- Active participation in another therapeutic clinical trial
- Patient unable to provide written consent on their own behalf
About this study
This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.
Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.
The Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.
- Being tested
- Optune TTF device
- Keywords
- PCNSL, primary central nervous system lymphoma
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optune TTF deviceDevice
portable device which produces electrical fields
| Study group | Role | What they receive |
|---|---|---|
| Optune TTF Device | Experimental | Optune TTF treatment Receives: Device: Optune TTF device |
| Historical matched control | No intervention | age-matched historical controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Time
Overall survival time
Measured: 4 years
Secondary outcomes (4)
Progression-Free Survival Time
Progression-free survival time
Measured: 2 years
One-Year Survival Rate
One-year survival rate
Measured: 1 year
Radiographic Response Rate
Tumor response by MRI measurement
Measured: 2 years
Steroid & Antiepileptic Use
use of concomitant steroids and antiepileptic use
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start31 Aug 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020
Why it stopped: Study never initiated, PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System Neoplasms, PrimaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective group (non-randomized) compared to historical matched controls
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530605
- Sponsor's protocol ID
- Optune TTF in PCNSL
- Status last verified
- Aug 2020
- First submitted
- 8 May 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT03530605
- Acronym / sponsor ID
- Optune TTF in PCNSL
- Keywords
- PCNSL, primary central nervous system lymphoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated, PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.
Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.
The Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective group (non-randomized) compared to historical matched controls
| Arm | Type | Receives |
|---|---|---|
| Optune TTF Device | Experimental | Device: Optune TTF deviceOptune TTF treatment |
| Historical matched control | No intervention | –age-matched historical controls |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histological de novo diagnosis of PCNSL
- Tumor located in the supra-tentorial brain region
- Karnofsky performance score of 70 or above
- Ineligible for chemotherapy due to age or other co-morbidities
- Life expectancy of at least 3 months
Key exclusion criteria (8 listed)
- Second or subsequent recurrence of PCNSL
- Patient wishes to receive systemic treatment
- Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)
- Skull defect without replacement
- Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment
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 |
|---|---|---|
| Optune TTF deviceportable device which produces electrical fields | Device | Optune TTF Device |
Primary outcome
Overall Survival Time
Time frame: 4 years
Overall survival time
4 secondary outcomes
Progression-Free Survival Time
Time frame: 2 years
One-Year Survival Rate
Time frame: 1 year
Radiographic Response Rate
Time frame: 2 years
Steroid & Antiepileptic Use
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Optune TTF device in people with Central Nervous System Neoplasms, Primary, run by Saint Luke's Health System.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival Time (time frame: 4 years). 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 2 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.