A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 10
- 主要终点
- Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
研究概览
简要总结
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M
- •Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
- •Negative surgical margins ( ≥ 0.2 cm) after final surgery.
- •Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
- •Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
- •Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
- •Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
- •Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.
- •Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
- •PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
- •Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.
排除标准
- •Pregnancy or breast-feeding.
- •Have collagen-vascular disease.
- •Inadequate surgical margins ( < 0.2 cm) after final surgery.
- •Subjects with persistent malignant/suspicious micro-calcifications.
- •Gross multifocal disease and microscopic disease greater than 3.0 cm.
结局指标
主要结局
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
时间窗: 5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
时间窗: 2-5 years
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
次要结局
- Dosimetric comparison(5-10 days)
- Acute skin reactions(6 months)
- Ipsilateral breast event(5-15 years)
- Cause specific survival(5-15 years)
- Cosmetic outcomes after APBI(2-5 years)
- Disease free survival(5-15 years)
- Overall survival(5-15 years)