A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer - Breast Cancer II

Karasawa Kumiko0 sites30 target enrollmentFebruary 25, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

Karasawa Kumiko

•1\. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ.
•2\. Tumor size \<\=20 mm on MRI.
•3\. No massive LVSI or EIC.
•4\. No lymphenode metastasis (\>2 mm). Sentinel lymph node biopsy is performed prior this study.
•5\. No distant metastasis.
•6\. Performance status (ECOG) of 0 to 2\.
•7\. 20 years old or older.
•8\. A life expectancy of at least 6 months.
•9\. Written informed consent.

•1\. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease).
•2\. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular\-targeted agents for breast cancer in same side.
•3\. Active other malignancy
•4\. The distanse between skin surface and tumor (including EIC) \<\=5 mm.
•5\. Previous radiation therapy for breast cancer in same side.
•6\. Eligible patients for Breast cancer I or Breast cancer III.
•7\. Pregnancy, pregnancy potential.
•8\. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.