JPRN-jRCTs032180154招募中1 期
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 个研究点目标入组 30 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
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