Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Rate of successfully delivered accelerated partial breast irradiation
研究概览
简要总结
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer.
PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
详细描述
OBJECTIVES:
Primary
- To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast.
- To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation.
Secondary
- To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0.
- To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale.
- To assess the incidence and type of adverse events in the breast of these patients.
- To assess the incidence and type of procedure-related complications in these patients.
- To determine local control and pattern of recurrence in these patients.
- To determine disease-free survival (distant and recurrence-free survival) of these patients.
- To determine overall survival of these patients.
- To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales.
- To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale.
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
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically proven invasive ductal carcinoma of the breast
- •Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
- •No T2 (tumor size > 3 cm) or T3 disease
- •No lymph node (L0) or hemangiosis (V0) invasion
- •Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast
- •No multifocal/multicentric disease
- •Previously treated with breast-conserving surgery with adequate axillary node management
- •Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ [DCIS]) on histology
- •Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan
- •Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study
- •Breast size amenable to partial breast irradiation (i.e., > A-cup size)
- •No other pathological invasive tumor or DCIS
- •No associated extensive DCIS component (< 25%)
- •No associated Paget's disease of the nipple
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No breast implants
- •No collagen vascular disease
- •No psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior radiotherapy
- •No concurrent chemotherapy
- •Sequential chemotherapy allowed
- •Concurrent hormonal therapy allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm II
Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
Rate of successfully delivered accelerated partial breast irradiation
时间窗: Never established as trial terminated
次要结局
- Disease-free survival (distant and recurrence-free survival)(Never established as trial terminated)
- Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0(Never established as trial terminated)
- Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale(Never established as trial terminated)
- Local control and pattern of recurrence(Never established as trial terminated)
- Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales(Never established as trial terminated)
- Incidence and type of procedure-related complications(Never established as trial terminated)
- Incidence and type of adverse events in the breast(Never established as trial terminated)
- Overall survival(Never established as trial terminated)