Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.

NCT ID: NCT06716775

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2028-10-30

Brief Summary

This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .

Conditions

NSCLC Brain Metastasis

Keywords

TTF; NSCLC brain metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TTF+Best Standard of Care

Group Type: EXPERIMENTAL

Tumor treating felds (TTF)

Intervention Type: DEVICE

Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.

Best Standard of Care

Intervention Type: OTHER

Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Best Standard of Care

Group Type: ACTIVE_COMPARATOR

Best Standard of Care

Intervention Type: OTHER

Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Interventions

Tumor treating felds (TTF)

Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.

Intervention Type: DEVICE

Best Standard of Care

Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The age of the subject was between 18 and 75 years old (inclusive), regardless of gender;

2. The predicted survival time was ≥3 months;

3. Newly diagnosed with NSCLC brain metastasis;

4. MRI imaging showed 1-10 unresectable brain metastases;

5. Karnofsky performance status (KPS) score ≥70;

6. Able to operate the TTF independently or with the help of a caregiver;

7. Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial;

8. Voluntarily signed the informed consent form.

Exclusion Criteria

1. Positive driver genes;

2. Recurrent brain metastasis of NSCLC;

3. Suffering from severe cerebral edema;

4. Leptomeningeal metastases;

5. Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:

1. platelet count < 100×103/μL;

2. absolute neutrophil count < 1.5×103/μL;

d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L);

6. There were infection, ulcer and unhealed wound in the skin where the electrode was applied；

7. Patients allergic to conductive hydrogels or medical adhesives;

8. Those who are pregnant or preparing to become pregnant or who are breastfeeding;

9. Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ligang Xing Dr Xing, Doctor

Role: CONTACT

Phone: (0531)87984777

Email: xinglg@medmail.com.cn

Other Identifiers

HL-10

Identifier Type: -

Identifier Source: org_study_id