Last updated: February 27, 2022
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting
Phase
1
Condition
Brain Metastases
Neoplasm Metastasis
Treatment
N/AClinical Study ID
NCT04967027
BM V1.0/2020-08-01
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 hasa 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, brainstimulators, severe intracranial edema, increased intracranial pressure leading tomidline structures exceeding 5 mm, optic nerve head edema, disturbance ofconsciousness, 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 ofnormal 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
Study Design
Total Participants: 5
Study Start date:
August 01, 2020
Estimated Completion Date:
December 01, 2022
Connect with a study center
Xiangya Hospital Central South University
Changsha, Hunan 410000
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.