NL-OMON38251招募中3 期
A randomised Phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast - BOOG 2009-03/BIG 3-07/TROG 07.01/DCIS
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 300 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
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
- 18 至 99（—）
入选标准
- •- Women with completely excised non-low risk DCIS of the breast treated by breast conserving surgery may be admitted to the study. Clinicians may enter patients onto the study, guided by individual equipoise, within the eligibility requirements of the study. ;- Women aged >=18 years ;- Histologically proven DCIS of the breast without an invasive component. ;- Bilateral mammograms performed within 6 months prior to randomisation. ;- Clinically node-negative. ;- Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of 1 mm*.
- •*Patients with superficial or deep resection margin of < 1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.;- Women who are at high risk of local recurrence due to: ;- Age < 50 years; OR
- •- Age 50 years plus at least one of the following:
- •Symptomatic presentation
- •Palpable tumour
- •Multifocal disease
- •Microscopic tumour size >= 1.5 cm in maximum dimension
- •Intermediate or high nuclear grade
- •Central necrosis
- •Comedo histology
- •Radial* surgical resection margin < 10 mm
- •*Patients with superficial or deep resection margin of < 10 mm are eligible if surgery has not removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia. ;- Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT. ;- Ability to tolerate protocol treatment. ;- Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure. ;- ECOG performance status 0, 1 or 2. ;- Patient*s life expectancy > 5 years. ;- Availability for long-term follow-up. ;- Written informed consent.
排除标准
- •- Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of 1 mm*.
- •*Patients with superficial and/or deep margin of < 1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
- •- Presence of tumour cells in lymph nodes detected using H & E or immunohistochemical examination (if lymph node biopsy or dissection has been performed). ;- Locally recurrent breast cancer. ;- Previous DCIS or invasive cancer of the contralateral breast. ;- Other concurrent or previous malignancies except: Non-melanomatous skin cancer; Carcinoma in situ of the cervix or endometrium; and Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence. ;- Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). ;- ECOG performance status >=3. ;- Women who are pregnant or lactating.
研究者
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