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| Name | Class |
|---|---|
| Shandong Cancer Hospital and Institute | OTHER |
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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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTF+Best Standard of Care | Experimental |
| |
| Best Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor treating felds (TTF) | Device | Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial tumor progression-free survival (iPFS) | Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from the date of treatment until death due to any cause. | 3 years |
| Objective response rate (ORR) | Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). |
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Inclusion Criteria:
Exclusion Criteria:
Positive driver genes;
Recurrent brain metastasis of NSCLC;
Suffering from severe cerebral edema;
Leptomeningeal metastases;
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:
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);
There were infection, ulcer and unhealed wound in the skin where the electrode was appliedï¼›
Patients allergic to conductive hydrogels or medical adhesives;
Those who are pregnant or preparing to become pregnant or who are breastfeeding;
Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligang Xing Dr Xing, Doctor | Contact | (0531)87984777 | xinglg@medmail.com.cn |
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| Best Standard of Care | Other | Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone. |
|
| 3 years |
| Time to neurocognitive failure | 3 years |
| Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months | 3 years |
| Neurocognitive failure-free survival | 3 years |
| Rate of decline in cognitive function | 3 years |
| Number of participants with adverse events (AEs) | Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments | 3 years |