NSCLC Brain Metastasis
Conditions
Keywords
TTF, NSCLC brain metastasis
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) .
Interventions
DEVICETumor treating felds (TTF)
Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.
Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.
Sponsors
Shandong Cancer Hospital and Institute
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial tumor progression-free survival (iPFS) | 3 years | Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 3 years | Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). |
| Time to neurocognitive failure | 3 years | — |
| Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months | 3 years | — |
| Overall Survival (OS) | 3 years | Defined as the time from the date of treatment until death due to any cause. |
| Rate of decline in cognitive function | 3 years | — |
| Number of participants with adverse events (AEs) | 3 years | Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments |
| Neurocognitive failure-free survival | 3 years | — |
Contacts
Primary ContactLigang Xing Dr Xing, Doctor
Outcome results
None listed