A Prospective Randomized Controlled Clinical Trial of Prophylactic Cranial Irradiation in Metastatic HER-2 positive Breast Cancer.

Ratchadapiseksompotch research fund0 sites235 target enrollmentJune 12, 2017

Overview

No summary available.

Registry

who.int

Start Date

June 12, 2017

End Date

June 30, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Ratchadapiseksompotch research fund

•1\.MetastaticHER\-2 positive breast cancer patients who had HER\-2 positive on immunohistochemistry or fluorescence in situ hybridization test.
•2\.No brain metastasis is noted
•3\.Eastern Cooperative Oncology Group (ECOG) performance status \<\=2
•4\.More than 18 years of age.
•5\.General physical conditions must be compatible with the radio\-therapeutic treatment.
•6\.Patients give permissions literally in the study informed consent form prior to participation.
•7\. The blood tests have to be fulfilled of WBC \>\=3000, platelet \>\=100,000, creatinine \<\=1\.5 mg/do, creatinine clearance \>\=60ml/min

•1\. History of previous cranial radiation or neurosurgery
•2 .History of cerebrovascular disease or neurological disorder including seizure.
•3 .Known or suspected brain or meningeal metastasis by present of signs of raised intra\-cranial pressure, seizure, focal symptom, cognitive dysfunction and proved by MRI to have brain metastases.
•4 .Patient with CNS disease.
•5 .Active untreated infection which increases risk of treatment complication.
•6 .Major medical or psychiatric illnesses that would affect to the outcome, completion of therapy, the follow up and without potential in understand the side effects and risks of the therapy.
•7 .pregnant women.