NCT00068263已完成1 期
A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.
详细描述
OBJECTIVES:
- Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.
- Determine the cosmetic results in patients treated with this regimen.
- Determine the complication rates in patients treated with this regimen.
- Determine the local control rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.
Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer
- •Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1)
- •Unifocal disease (single focus that can be encompassed by one lumpectomy)
- •The following histologies are eligible:
- •Invasive ductal
- •Medullary
- •Papillary
- •Colloid (mucinous)
- •No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)
- •No nonepithelial breast malignancies such as sarcoma or lymphoma
- •Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy
- •Six surgical clips in place delineating the margins of the tylectomy cavity
- •Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation
- •Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present
- •No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy
- •No more than 3 positive axillary nodes
- •No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy
- •No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative
- •No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition:
- •More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue
- •Intraductal carcinoma with microinvasion
- •No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
- •No evidence of suspicious microcalcifications
- •No Paget's disease of the nipple
- •No skin involvement by disease, regardless of tumor size
- •No distant metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •At least 2 years
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Technically suitable for breast radiotherapy
- •No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
- •No other medical condition that would limit life expectancy
- •No psychiatric or addictive disorders that would preclude giving informed consent
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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