JPRN-jRCT1032220561招募中2 期
A single center, prospective, single-arm, confirmatory study of accelerated partial breast irradiation using intensity modulated radiotherapy technique after breast conserving surgery.
Murofushi Keiko0 个研究点目标入组 70 人开始时间: 2023年1月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- >= 60age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. All of the following conditions were met prior to surgery.
- •a Single tumor deteceted in MRI.
- •b No lung metastasis detected in chest X-ray.
- •c No neoadjuvant treatment.
- •d No distant metastasis detected in all preoperative examinations.
- •2. Additional resection during partial mastectomy is allowed.
- •3. Eligibility criteria of histopathology,
- •a DCIS/IDC, pTis-1N0M0, tumor size =< 2 cm.
- •c No cancer cells within 2 mm of resection margin.
- •d Not multiple tumors.
- •4. Receiving appropriate adjuvant therapy (may not be necessary).
- •5. Female (Explanation and consent can be given in Japanese).
- •6. 60 years or older.
- •7. ECOG Performance status 0 or 1.
- •8. No history of radiation therapy to the chest for any disease.
- •9. Major organ function is preserved.
- •10. Written informed consent is obtained.
排除标准
- •1. Active collagen diseases.
- •2. Simultaneous or metachronous (within 2 years) multiple cancers.
- •3. Active infectious disease requiring systemic therapy.
- •4. Receiving continuous administration of steroids (> 10mg/day) or immunosuppressant treatments.
- •5. Diabetes mellitus uncontrollable under proper treatment.
- •6. Other conditions judged as inappropriate for the study by the investigator.
研究者
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