NCT00077168Unknown2 期
Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy
Institute of Cancer Research, United Kingdom58 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 2,000
- 试验地点
- 58
- 主要终点
- Local tumor control (invasive and in situ local recurrence)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.
详细描述
OBJECTIVES:
Primary
- Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone.
- Compare the quality of life of patients treated with these regimens.
Secondary
- Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.
- Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component
- •Microinvasion (defined as 1 or more foci of invasion each < 1 mm) allowed
- •Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required
- •Maximum microscopic tumor diameter < 30 mm (< 15 mm if grade 3 tumor)
- •Planning to receive adjuvant tamoxifen or anastrozole for 5 years
- •Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II
- •Hormone receptor status:
- •Estrogen receptor positive OR
- •Progesterone receptor positive
- •More than 10% tumor staining for receptor OR a cutpoint of ≥ 2
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Premenopausal, perimenopausal, or postmenopausal
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No prior deep vein thrombosis
- •No prior pulmonary embolus
- •No unexplained postmenopausal bleeding
- •No contraindication to full-dose radiotherapy to the breast
- •No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •See Disease Characteristics
- •No prior tamoxifen or raloxifene use for more than 3 months in duration
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •No prior mastectomy
- •No concurrent anticoagulants
排除标准
- 未提供
结局指标
主要结局
Local tumor control (invasive and in situ local recurrence)
次要结局
- Mastectomy rate
- Pattern of relapse in the breast
- Contralateral primary
- Breast cancer metastases
- Mortality
- Quality of life
- Molecular markers that predict ipsilateral tumor recurrence
研究者
研究点 (58)
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