Condition or disease | Intervention/treatment | Phase |
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Extensive Stage Lung Small Cell Carcinoma Limited Stage Lung Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 | Other: Questionnaire Administration Device: Tumor Treating Fields Therapy | Phase 2 |
PRIMARY OBJECTIVE:
I. Observed rate of brain metastases following TTFields therapy at 6 months.
SECONDARY OBJECTIVES:
I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases.
OUTLINE:
Participants will receive TTFields therapy on a continuous basis (i.e., 18-24 hours a day, 7 days a week) for a period of 12 months or until the development of brain metastases, whichever comes first. Participants will be able to carry the device in an over-the-shoulder bag or backpack so that they can receive continuous at-home treatment. The investigator or other designated healthcare provider will provide detailed instructions regarding the placement/replacement and positioning of the transducer arrays on the participants head. TTFields are applied to the shaved scalp via two pairs of orthogonally positioned transducer arrays. Each pair of transducer arrays will be centered on the participants shaved head such that one pair is placed on the left and right side of the head, and the second pair placed anteriorly and posteriorly. Transducer arrays should be replaced every 2 to 3 days, with a slight relocation of the new arrays ~2 cm from the prior location.
After completion of study treatment, patients are followed up periodically.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 106 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer |
Actual Study Start Date : | June 11, 2019 |
Estimated Primary Completion Date : | June 20, 2021 |
Estimated Study Completion Date : | December 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Prevention (TTFields therapy, questionnaire)
Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
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Other: Questionnaire Administration
Ancillary studies
Device: Tumor Treating Fields Therapy Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Other Names:
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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC
Exclusion Criteria:
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)
Contact: Timur Mitin, MD | 503-494-1080 | trials@ohsu.edu |
United States, Arizona | |
Mayo Clinic Hospital in Arizona | Not yet recruiting |
Phoenix, Arizona, United States, 85054 | |
Contact: Terence T. Sio, MD, MS 480-342-1267 sio.terence@mayo.edu | |
Principal Investigator: Terence T. Sio, MD, MS | |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | Not yet recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Joshua D. Palmer, MD 614-293-8415 joshua.palmer@osumc.edu | |
Principal Investigator: Joshua D. Palmer, MD | |
United States, Oregon | |
OHSU Knight Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Timur Mitin, MD 503-494-1080 trials@ohsu.edu | |
Principal Investigator: Timur Mitin, MD | |
United States, Washington | |
University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Jing Zeng, MD 206-598-4100 | |
Principal Investigator: Jing Zeng, MD |
Principal Investigator: | Timur Mitin, MD | OHSU Knight Cancer Institute |
Tracking Information | |||||
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First Submitted Date ICMJE | June 20, 2019 | ||||
First Posted Date ICMJE | June 24, 2019 | ||||
Last Update Posted Date | December 16, 2020 | ||||
Actual Study Start Date ICMJE | June 11, 2019 | ||||
Estimated Primary Completion Date | June 20, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence of small cell lung cancer (SCLC) brain metastases at 6 months [ Time Frame: 6 months following start of tumor treating fields (TTFields) therapy ] | ||||
Original Primary Outcome Measures ICMJE |
Incidence of small cell lung cancer (SCLC) brain metastases at 6 months [ Time Frame: 6 months following start of TTFields therapy ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer | ||||
Official Title ICMJE | Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer | ||||
Brief Summary | This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields ("TTFields") within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells. | ||||
Detailed Description |
PRIMARY OBJECTIVE: I. Observed rate of brain metastases following TTFields therapy at 6 months. SECONDARY OBJECTIVES: I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases. OUTLINE: Participants will receive TTFields therapy on a continuous basis (i.e., 18-24 hours a day, 7 days a week) for a period of 12 months or until the development of brain metastases, whichever comes first. Participants will be able to carry the device in an over-the-shoulder bag or backpack so that they can receive continuous at-home treatment. The investigator or other designated healthcare provider will provide detailed instructions regarding the placement/replacement and positioning of the transducer arrays on the participants head. TTFields are applied to the shaved scalp via two pairs of orthogonally positioned transducer arrays. Each pair of transducer arrays will be centered on the participants shaved head such that one pair is placed on the left and right side of the head, and the second pair placed anteriorly and posteriorly. Transducer arrays should be replaced every 2 to 3 days, with a slight relocation of the new arrays ~2 cm from the prior location. After completion of study treatment, patients are followed up periodically. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Prevention (TTFields therapy, questionnaire)
Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
106 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2022 | ||||
Estimated Primary Completion Date | June 20, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 22 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03995667 | ||||
Other Study ID Numbers ICMJE | STUDY00018029 NCI-2020-00574 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) STUDY00018029 ( Other Identifier: OHSU Knight Cancer Institute ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Timur Mitin, OHSU Knight Cancer Institute | ||||
Study Sponsor ICMJE | OHSU Knight Cancer Institute | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | OHSU Knight Cancer Institute | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |