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

Primary Purpose

Extensive Stage Lung Small Cell Carcinoma, Limited Stage Lung Small Cell Carcinoma, Stage I Lung Cancer AJCC v8

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Questionnaire Administration

Tumor Treating Fields Therapy

About this trial

This is an interventional prevention trial for Extensive Stage Lung Small Cell Carcinoma

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic Hospital in Arizona
OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (TTFields therapy, questionnaire)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of small cell lung cancer (SCLC) brain metastases at 6 months

Secondary Outcome Measures

Incidence of SCLC brain metastases at 12 months

Overall survival

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

Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE)

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)

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

Full Information

NCT ID

NCT03995667

First Posted

June 20, 2019

Last Updated

August 11, 2023

Sponsor

OHSU Knight Cancer Institute

Collaborators

NovoCure Ltd., Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT03995667

Brief Title

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

Official Title

Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Low accrual

Study Start Date

June 11, 2019 (Actual)

Primary Completion Date

August 4, 2022 (Actual)

Study Completion Date

August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

NovoCure Ltd., Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prevention (TTFields therapy, questionnaire)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Device

Intervention Name(s)

Tumor Treating Fields Therapy

Other Intervention Name(s)

Alternating Electric Field Therapy, TTF, TTFields

Intervention Description

Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Incidence of SCLC brain metastases at 12 months

Time Frame

12 months following start of TTFields therapy

Title

Overall survival

Description

Time Frame

Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)

Title

Incidence of TTfield related adverse events

Time Frame

Continuously following start of TTFields therapy (up to 12 months)

Title

Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE)

Description

Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.

Time Frame

Continuously following start of TTFields therapy (up to 12 months)

Title

Change in quality of life over time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)

Description

Time Frame

6 and 12 months following start of TTFields therapy

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timur Mitin, MD

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Hospital in Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

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

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