Brain metastases in non-small cell lung cancer
Conditions
Interventions
Experimental group:TTF+SRS
Control group:SRS
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects between the ages of 18 and 75 years (including 18 and 75 years old), regardless of gender; 2. Estimated survival >=3 months; 3. Newly diagnosed with NSCLC brain parenchymal metastases, and their extracranial or intracranial lesions have been histologically or cytologically confirmed as primary or metastatic NSCLC. If the original malignant tumor has been pathologically diagnosed for more than 5 years, the lesion tissue should be obtained for pathological confirmation; 4. Number of previous systematic treatment lines for non-small cell lung cancer=70 points; 9. Able to operate the tumor treating field therapy instrument independently or with the help of nursing staff; 10. Adverse events (AEs) after prior treatment, which should be restored to normal or CTCAE1 grade (except for alopecia, stable neurotoxicity and laboratory examination abnormalities judged by the investigator to be of no clinical significance); 11. Female subjects of childbearing potential have a negative serum pregnancy test result. Female subjects of childbearing potential who agree to use effective contraception (such as hormonal or barrier methods or abstinence, etc.) for the duration of the study and for 1 month after the end of treatment; 12. Male subjects agree to use effective birth control (such as barrier method or abstinence, etc.) during the study period and for 1 month after the end of treatment, and do not donate sperm; 13. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Unambiguous source documentation confirmed with EGFR mutations, ALK fusion positive, ROS1 fusion positive, BRAF V600 mutations, NTRK fusion positive, MET exon 14 skipping mutations, RET fusion positive, and other driver gene mutations with marketed and available targeted drug therapy; 2. Received directed anti-tumor therapy for brain metastases before enrollment, including but not limited to whole-brain radiotherapy (WBRT), intrathecal chemotherapy, etc.; 3. Recurrent non-small cell lung cancer brain metastases; 4. Brain metastases need to be surgically removed; 5. Infratentorial tumors; 6. Suffering from severe cerebral edema, with a risk of causing brain herniation; 7. Midline displacement>10mm; 8. Uncontrolled refractory epilepsy; 9. Severe increase in intracranial pressure with uncontrolled leptomeningeal metastases (clinically manifested as severe papilledema, vomiting, nausea or loss of consciousness); 10. Cancer requiring the implementation of other anti-tumor therapy within 2 years prior to enrollment, excluding treated stage I prostate cancer, cervical cancer in situ, breast cancer in situ, and non-melanoma skin cancer; 11. Patients with abnormal bone marrow and heart, liver and kidney function: a) neutrophil count 1.5× upper limit of normal (ULN); c) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5×ULN; d) Serum creatinine >1.5×ULN; 12. Have a history of severe cardiovascular disease, including but not limited to second/third degree heart block; severe ischemic heart disease; New York Heart Association (NYHA) class >= congestive heart failure (mild limitation of physical activity; comfortable at rest, but normal activity can cause fatigue, palpitations, or difficulty breathing); 13. Serious infection before the first dose, judged by the investigator to be ineligible to participate in the trial; 14. History of HIV infection (known HIV1/2 antibody positive), known active syphilis infection; 15. Known active hepatitis, or HBV and HIV co-infection (HBV reference: HBsAg positive, and HBV DNA test value greater than 500 IU; Hepatitis C reference: HCV antibody positive, and HCV virus titer above the upper limit of normal); 16. Those who have a clear history of neurological diseases or mental disorders, such as dementia, or who regularly use any illegal drugs or have a history of drug abuse (including alcohol) (within the last year) that may affect trial compliance; 17. There is infection, ulcer, or unhealed wound on the skin at the electrode application site, and the investigator judges that it is not suitable for applying the electrode; 18. Implantable electronic medical devices, such as pacemakers, in the body; 19. Skull defects or residual metal fragments inside the skull (except for titanium plates or titanium nails used in skull surgery); 20. Known allergies to medical adhesives or hydrogels; 21. Those who are pregnant or breastfeeding; 22. Received other drug clinical trial treatment within 3 months before randomization, or received other device clinical trial treatment within 1 month before randomization; 23. Subjects with poor compliance as judged by the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival time; | — |
Countries
China
Contacts
Public ContactLigang Xing
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed