Brain Metastases
Conditions
Keywords
Tumor Treating Fields; Brain metastases;
Brief summary
Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.
Interventions
DEVICEASCLU-300 TTF
BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team; * age from 18 to 65 year-old; * patients have been progressed from standard therapy (drug/radiation resistance) * KPS more than 70 score; * anticipated OS more than 3 months; * signed consent form.
Exclusion criteria
* unable to take TTFields more than 18 hours each day; * unable to follow-up till progression; * the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes * pregnant women; * last drug within 4 weeks, last radiation within 3 months, take other trials; * other heavy diseases like heavy infection; * other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc. * blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT \> 3 times the upper limit of normal; B. Total bilirubin\> upper limit of normal value; C. Renal impairment: serum creatinine\>1.7mg /dL (\>150 mol/L); D. Coagulopathy: PT or APTT \>1.5 times normal; E. Platelets counts \< 100x10\^9/L; F. Absolute neutrophils count \< 1x10\^9/L; G. Hemoglobin \< 100g/L; * other conditions physicians not suggest to take the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The treatment-related adverse events | 12 months | Number of patients who experienced a treatment-related adverse event. |
| Time to Progression | 12 months | Time to progression of patients with brain metastases |
| Overall Survival Rate | 12 months | Number of patients alive at 12 months |
Countries
China
Contacts
Primary ContactFangkun Liu, MD
Backup ContactLiyang Zhang, MD
Outcome results
None listed