Extensive Stage Small Cell Lung CarcinomaNCT03607682
Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer
A study testing Tumor Treating Fields (TTF) Therapy, NovoTTF-200A Device and Quality-of-Life Assessment in people with Extensive Stage Small Cell Lung Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Carcinoma
- What is being tested?
- Tumor Treating Fields (TTF) Therapy, NovoTTF-200A Device and Quality-of-Life Assessment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 13 Jul 2020
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life expectancy of > 3 months
- Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
- Karnofsky performance status (KPS) > 70
- Neutrophil count > 1.5 x 10^9/L
- Platelet count > 100 x 10^9/L
- Bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x ULN or < 5 x ULN if patient has documented liver metastases
- Serum creatinine < 1.5 x ULN
Who cannot join
- Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
- History of other prior malignancy within the past 5 years except for superficial skin cancers
- No severe comorbidities:
- History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
- History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
- History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment
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- Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
- History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
- Known allergies to medical adhesives or hydrogel
- Unable to operate the NovoTTF-200A device independently or with the help of a caregiver
- If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment
- Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol)
- Prior clinical trial participation with brain directed therapy
- Concurrent treatment clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.
Read the detailed description
PRIMARY OBJECTIVES:
- To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.
SECONDARY OBJECTIVES:
- To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.
IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
OUTLINE:
Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure.
After completion of study treatment, participants are followed up at 8 weeks.
- Being tested
- Tumor Treating Fields (TTF) Therapy, NovoTTF-200A Device, Quality-of-Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Treating Fields (TTF) TherapyProcedure or surgery
Undergo TTF therapy
NovoTTF-200A DeviceDevice
Undergo TTF therapy
Quality-of-Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (TTF therapy, NovoTTF-200A device) | Experimental | Not described Receives: Procedure: Tumor Treating Fields (TTF) Therapy; Device: NovoTTF-200A Device; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Continuing Therapy Until Intracranial Tumor
Count of patients developed intracranial tumor divided by total number of patients.
Measured: Up to 6 months
Secondary outcomes (8)
Time to Intracranial Failure
Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
Measured: Up to 3 years
Overall Survival
Estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Rate of Intracranial Failure
Estimated using the cumulative incidence function
Measured: Up to 12 months
Rate of Decline in Cognitive Function
Measured by Hopkins Verbal Language Test
Measured: Up to 12 months
Time to Neurocognitive Failure
Measured by Hopkins Verbal Language Test
Measured: Up to 3 years
Neurocognitive Failure-free Survival
Measured by Hopkins Verbal Language Test
Measured: Up to 3 years
Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
Measured: Up to 3 years
Incidence of Adverse Events
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start5 Sep 2018
- Primary completion2 Jun 2020
- Study completion13 Jul 2020
Why it stopped: PI left institution and loss of funding
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 Extensive Stage Small Cell Lung CarcinomaStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Principal investigator, Wade Iams, Vanderbilt-Ingram Cancer Center
- Investigators
- Albert Attia, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607682
- Sponsor's protocol ID
- VICC THO 1747
- Other IDs
- NCI-2018-01428
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2018
- Last updated
- 4 Aug 2020
- 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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03607682
- Acronym / sponsor ID
- VICC THO 1747
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution and loss of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.
Detailed description
PRIMARY OBJECTIVES:
- To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.
SECONDARY OBJECTIVES:
- To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.
IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
OUTLINE:
Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure.
After completion of study treatment, participants are followed up at 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (TTF therapy, NovoTTF-200A device) | Experimental | Procedure: Tumor Treating Fields (TTF) Therapy, Device: NovoTTF-200A Device, Other: Quality-of-Life Assessment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Life expectancy of > 3 months
- Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
- Karnofsky performance status (KPS) > 70
- Neutrophil count > 1.5 x 10^9/L
- Platelet count > 100 x 10^9/L
Key exclusion criteria (15 listed)
- Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
- History of other prior malignancy within the past 5 years except for superficial skin cancers
- No severe comorbidities:
- Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
- Known allergies to medical adhesives or hydrogel
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 |
|---|---|---|
| Tumor Treating Fields (TTF) TherapyUndergo TTF therapy | Procedure or surgery | Prevention (TTF therapy, NovoTTF-200A device) |
| NovoTTF-200A DeviceUndergo TTF therapy | Device | Prevention (TTF therapy, NovoTTF-200A device) |
| Quality-of-Life AssessmentAncillary studies | Other | Prevention (TTF therapy, NovoTTF-200A device) |
Primary outcome
Percentage of Patients Continuing Therapy Until Intracranial Tumor
Time frame: Up to 6 months
Count of patients developed intracranial tumor divided by total number of patients.
8 secondary outcomes
Time to Intracranial Failure
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Rate of Intracranial Failure
Time frame: Up to 12 months
Rate of Decline in Cognitive Function
Time frame: Up to 12 months
Time to Neurocognitive Failure
Time frame: Up to 3 years
Neurocognitive Failure-free Survival
Time frame: Up to 3 years
Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Time frame: Up to 3 years
Incidence of Adverse Events
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- 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.
Albert Attia, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Treating Fields (TTF) Therapy, NovoTTF-200A Device and Quality-of-Life Assessment in people with Extensive Stage Small Cell Lung Carcinoma, run by Vanderbilt-Ingram Cancer Center 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 8 inclusion and 15 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 4 Aug 2020. 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 Aug 2020). 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?
Percentage of Patients Continuing Therapy Until Intracranial Tumor (time frame: Up to 6 months). 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 4 Aug 2020.