Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 636
- 试验地点
- 369
- 主要终点
- Local recurrence (e.g., invasive or noninvasive recurrence)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
详细描述
OBJECTIVES:
- Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.
- Compare distant disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.
- Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
干预措施: tamoxifen citrate (Drug)
Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
干预措施: adjuvant therapy (Procedure)
Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
干预措施: tamoxifen citrate (Drug)
Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
干预措施: adjuvant therapy (Procedure)
Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Local recurrence (e.g., invasive or noninvasive recurrence)
时间窗: From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
次要结局
- Overall survival(From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)
- Salvage mastectomy rate(Analysis occurs after all patients have been potentially followed for 5 years.)
- Invasive local recurrence(From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)
- Time to distant metastasis(From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)