NCT03995667

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

Terminated Phase 2 Results posted Last updated 30 October 2023

What this trial tests

Phase 2 trial testing Questionnaire Administration in Extensive Stage Lung Small Cell Carcinoma in 3 participants. Terminated before completion.

Timeline

11 June 2019

Primary endpoint
4 August 2022

4 August 2022

Quick facts

Lead sponsor	OHSU Knight Cancer Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	3
Start date	11 June 2019
Primary completion	4 August 2022
Estimated completion	4 August 2022
Sites	2 locations across United States

Drugs / interventions tested

• Questionnaire Administration
• Tumor Treating Fields Therapy

Conditions studied

• Extensive Stage Lung Small Cell Carcinoma — all drugs for Extensive Stage Lung Small Cell Carcinoma →
• Limited Stage Lung Small Cell Carcinoma — all drugs for Limited Stage Lung Small Cell Carcinoma →
• Stage I Lung Cancer AJCC v8 — all drugs for Stage I Lung Cancer AJCC v8 →
• Stage IA1 Lung Cancer AJCC v8 — all drugs for Stage IA1 Lung Cancer AJCC v8 →

Sponsor

OHSU Knight Cancer Institute

Who can join

22 and older, any sex, with Extensive Stage Lung Small Cell Carcinoma or Limited Stage Lung Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prevention (TTFields Therapy, Questionnaire)

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (1 terms — click to expand)

Reaction	System	Prevention (TTFields Thera…
Dermatitis	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03995667 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Treating Fields in the Management of Patients with Malignant Gliomas.
   Ghiaseddin AP, Shin D, Melnick K, Tran DD. · · 2020 · cited 79× · PMID 32734509 · DOI 10.1007/s11864-020-00773-5
2. Tumor Treating Fields: At the Crossroads Between Physics and Biology for Cancer Treatment.
   Carrieri FA, Smack C, Siddiqui I, Kleinberg LR, et al · · 2020 · cited 29× · PMID 33215030 · DOI 10.3389/fonc.2020.575992
3. Pulsed Electric Fields in Oncology: A Snapshot of Current Clinical Practices and Research Directions from the 4th World Congress of Electroporation.
   Campana LG, Daud A, Lancellotti F, Arroyo JP, et al · · 2023 · cited 20× · PMID 37444450 · DOI 10.3390/cancers15133340
4. Engineering the Tumor Immune Microenvironment through Minimally Invasive Interventions.
   Pal K, Sheth RA. · · 2022 · cited 11× · PMID 36612192 · DOI 10.3390/cancers15010196
5. Preventive strategies against brain metastases: current state of the art and future directions.
   Ippen FM, Konen FF, Hau P, Winkler F. · · 2026 · PMID 41928334 · DOI 10.1186/s42466-026-00467-7