NCT00909909进行中（未招募）2 期
Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
- To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
Secondary
- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
- To identify co-variates responsible for poor cosmetic outcome in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer, including 1 of the following subtypes:
- •Ductal carcinoma in situ
- •Invasive ductal carcinoma
- •Invasive lobular carcinoma
- •Medullary carcinoma
- •Papillary carcinoma
- •Colloidal (mucinous) carcinoma
- •Tubular carcinoma
- •Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
- •Tumor size ≤ 5 cm
- •Breast considered technically satisfactory for radiotherapy
- •Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
- •Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
- •Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
- •No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- •No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
- •If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
- •No more than 9 positive axillary lymph nodes
- •No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
- •No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
- •No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
- •No Paget disease of the nipple
- •No skin involvement, regardless of tumor size
- •No distant metastases
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Pre- or post-menopausal
- •ECOG performance status 0-1
- •No co-existing medical condition that would limit life expectancy to < 2 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
- •No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- •No psychiatric or addictive disorder that would preclude obtaining informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior radiotherapy for the current breast cancer
- •No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
- •Chemotherapy allowed provided the following criteria are met:
- •Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
- •Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
- •Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
- •May be initiated before, during, or after radiotherapy
- •No other concurrent chemotherapy, immunotherapy, or experimental medications
排除标准
- 未提供
研究组 & 干预措施
A
Active Comparator
3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
干预措施: External beam boost (Radiation)
A
Active Comparator
3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
干预措施: whole breast irradiation (Radiation)
B
Active Comparator
Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
干预措施: External beam boost (Radiation)
B
Active Comparator
Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
干预措施: whole breast irradiation (Radiation)
结局指标
主要结局
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
时间窗: 5 years
次要结局
- Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale(5 years)
- Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0(5 years)
研究者
Bruce G Haffty
Professor and Chairman, Department of Radiation Oncology
Rutgers, The State University of New Jersey
研究点 (4)
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