CTRI/2017/08/009197招募中2 期
Assessment of acute toxicities and early local recurrences in Post mastectomy breast cancer patients by Accelerated Hypo Fractionated Radiotherapy, a single arm clinical trial.
Dr Parthasarathy V1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年1月2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
- 65
- 试验地点
- 1
- 主要终点
- the incidence of grade II and above acute radiation induced dermatitis
研究概览
简要总结
This is a single arm clinical trial in which patients with breast cancer who have underwent Modified Radical Mastectomy will receive Post Mastectomy Radiotherapy [PMRT] with a dose of 42.5 Gy in 16 fractions over 3 weeks. The acute toxicities will be assessed using RTOG toxicity gradingscale. Late toxicity will be graded according to RTOG/EORTC Late RadiationMorbidity Scoring Schema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Biopsy proven patients of carcinoma breast who have underwent Modified Radical Mastectomy.
排除标准
- •Patient with ischemic heart disease or other cardiac ailments.
- •Previous history or irradiation to chest wall.
- •Presence of metastasis to liver, brain, contralateral breast, contralateral lymph nodes, bones.
- •Patients who have underwent Breast Conservation Surgery.
- •ECOG performance status > 3.
结局指标
主要结局
the incidence of grade II and above acute radiation induced dermatitis
时间窗: from the start of radiation until 3 months post treatment
次要结局
- incidence of other radiation induced toxicities(local recurrence of the tumor)
研究者
研究点 (1)
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