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出境医 / 临床实验 / Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer

Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer

Study Description
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.

Condition or disease Intervention/treatment Phase
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

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.
Other: Questionnaire Administration
Ancillary studies

Device: Tumor Treating Fields Therapy
Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Other Names:
  • Alternating Electric Field Therapy
  • TTF
  • TTFields

Outcome Measures
Primary Outcome Measures :
  1. Incidence of small cell lung cancer (SCLC) brain metastases at 6 months [ Time Frame: 6 months following start of tumor treating fields (TTFields) therapy ]

Secondary Outcome Measures :
  1. Incidence of SCLC brain metastases at 12 months [ Time Frame: 12 months following start of TTFields therapy ]
  2. Overall survival [ Time Frame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months) ]
    Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage).

  3. Incidence of TTfield related adverse events [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
  4. Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE) [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
    Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.

  5. Change in quality of life over time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) [ Time Frame: 6 and 12 months following start of TTFields therapy ]
    Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Summary of QoLs and its change over time will be presented graphically.

  6. Incidence of SCLC brain metastases [ Time Frame: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days) ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document
  • Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC

    • LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
    • ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
  • Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy
  • Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment
  • No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment
  • No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
  • Life expectancy of at >= 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60)
  • Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
  • Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)

    • External medical devices (e.g., insulin pumps) are permitted
  • Skull defect (e.g. missing bone with no replacement)
  • Shunt
  • Bullet fragments
  • Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  • Sensitivity to conductive hydrogels
  • Pregnant or lactating women
  • Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Timur Mitin, MD 503-494-1080 trials@ohsu.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
OHSU Knight Cancer Institute
NovoCure Ltd.
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Timur Mitin, MD OHSU Knight Cancer Institute
Tracking Information
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
 (submitted: February 6, 2020)
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
 (submitted: June 21, 2019)
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
 (submitted: December 11, 2020)
  • Incidence of SCLC brain metastases at 12 months [ Time Frame: 12 months following start of TTFields therapy ]
  • Overall survival [ Time Frame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months) ]
    Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage).
  • Incidence of TTfield related adverse events [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
  • Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE) [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
    Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.
  • Change in quality of life over time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) [ Time Frame: 6 and 12 months following start of TTFields therapy ]
    Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Summary of QoLs and its change over time will be presented graphically.
  • Incidence of SCLC brain metastases [ Time Frame: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Incidence of SCLC brain metastases at 12 months [ Time Frame: 12 months following start of TTFields therapy ]
  • Overall survival [ Time Frame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months) ]
    Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage)
  • Incidence of TTfield related adverse events [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
  • Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE) [ Time Frame: Continuously following start of TTFields therapy (up to 12 months) ]
    Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted
  • Change in quality of life over time: EORTC QLQ-C30 [ Time Frame: 6 and 12 months following start of TTFields therapy ]
    Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Summary of QoLs and its change over time will be presented graphically.
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.

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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Other: Questionnaire Administration
    Ancillary studies
  • Device: Tumor Treating Fields Therapy
    Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
    Other Names:
    • Alternating Electric Field Therapy
    • TTF
    • TTFields
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:
  • Other: Questionnaire Administration
  • Device: Tumor Treating Fields Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
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:

  • Ability to understand and the willingness to sign a written informed consent document
  • Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC

    • LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
    • ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
  • Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy
  • Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment
  • No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment
  • No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
  • Life expectancy of at >= 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60)
  • Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
  • Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)

    • External medical devices (e.g., insulin pumps) are permitted
  • Skull defect (e.g. missing bone with no replacement)
  • Shunt
  • Bullet fragments
  • Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  • Sensitivity to conductive hydrogels
  • Pregnant or lactating women
  • Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Timur Mitin, MD 503-494-1080 trials@ohsu.edu
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timur Mitin, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE
  • NovoCure Ltd.
  • Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Timur Mitin, MD OHSU Knight Cancer Institute
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

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