Trial Outcomes & Findings for Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer (NCT NCT03995667)

NCT ID: NCT03995667

Last Updated: 2023-10-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 6 months following start of tumor treating fields (TTFields) therapy
• Results posted on: 2023-10-30

Participant Flow

Participant milestones

Measure	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. Questionnaire Administration: Ancillary studies Tumor Treating Fields Therapy: Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Prevention (TTFields Therapy, Questionnaire) n=3 Participants 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. Questionnaire Administration: Ancillary studies Tumor Treating Fields Therapy: Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months following start of tumor treating fields (TTFields) therapy

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months following start of TTFields therapy

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data not collected.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months following start of TTFields therapy

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days)

Population: Data not collected.

Outcome measures

Outcome data not reported

Adverse Events

Prevention (TTFields Therapy, Questionnaire)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Prevention (TTFields Therapy, Questionnaire) n=3 participants at risk 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. Questionnaire Administration: Ancillary studies Tumor Treating Fields Therapy: Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Skin and subcutaneous tissue disorders Dermatitis

33.3% 1/3 • 18 months.

Additional Information

Dr. Timur Mitin, MD, PhD

Oregon Health & Science University

Phone: 503-494-8756

Email: mitin@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place