NCT01276938已完成2 期
Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Late toxicity
研究概览
简要总结
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
- •Age ≥ 45 and < 85
- •Tumor major diameter ≤ 2.5 cm
- •Negative surgical margins (≥ 5 mm)
- •Willingness to undergo follow up examinations
- •Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
- •Signed informed consent
排除标准
- •Ductal carcinoma in situ or lobular carcinoma
- •Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
- •Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- •Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
- •Collagen vascular disorders
研究组 & 干预措施
IORT 21 Gy
Active Comparator
Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm
干预措施: 21 Gy radiation (Radiation)
IORT 18 Gy
Experimental
Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.
干预措施: 18 Gy radiation (Radiation)
结局指标
主要结局
Late toxicity
时间窗: 5 years
Assessment of late toxicity using modified LENT scale
Cosmetic outcome
时间窗: 5 years
Assessment of cosmetic outcome according to semi-objective criteria
Early toxicity
时间窗: 6 months
Assessment of early toxicity using modified RTOG scale
次要结局
- Local Relapse Free Survival (LRFS)(10 years)
- Disease Free Survival (DFS)(10 years)
研究者
研究点 (1)
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