Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)
Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study
研究概览
详细说明
It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.
Primary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.
Null-hypothesis for primary end-point: The incidence of severe (>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.
Stratification:
- by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients
- by bra capsize: Capsize A-B; C; and D-D+
Treatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.
Clinical target volume (CTV) and Planning target volume (PTV) definition:
CTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction
Follow-up:
- ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.
- Mammography: at 6, 12, 18, 24 months, and annually thereafter
- Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter
- digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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-
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Budapest、匈牙利、H-1122
- National Institute of Oncology
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
- patient age > 40 years
- ECOG performance status: 0-1
- life expectancy >5 years
- invasive ductal, papillary, mucinous, medullary or tubular carcinoma
- unifocal tumor
- pathological tumor size < or = 30 mm
- pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
- surgical clips in the tumor bed
- pathological surgical free margins of at least 2 mm
- written informed consent of patients
Exclusion Criteria:
- Stage III-IV
- multifocal tumor
- extensive intraductal component (EIC)
- ductal or lobular carcinoma in situ (DCIS or LCIS)
- invasive lobular cancer (ILC)
- lymph-vascular invasion (LVI)
- contralateral breast cancer
- history of treatment for previous breast cancer
- lactation or breast feeding women
- Paget-disease of the nipple
- psychiatric disorder
- increased radiosensitivity (e.g. collagen vascular disease)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
|
9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
late radiation side-effect
大体时间：5 years
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Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme
|
5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cosmetic results
大体时间：5 years
|
cosmetic results at 5 years measured by the Harvard criteria
|
5 years
|
|
local tumor control
大体时间：5 years
|
Local tumor control defined as reappearance of the tumor in the ipsilateral breast
|
5 years
|
|
regional tumor control
大体时间：5 years
|
regional tumor control at 5 years
|
5 years
|
|
overall survival
大体时间：5 years
|
overall survival at 5 years
|
5 years
|
|
disease free survival
大体时间：5 years
|
disease free survival at 5 years
|
5 years
|
|
cancer specific survival
大体时间：5 years
|
cancer specific survival at 5 years
|
5 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
quality of life
大体时间：5 years
|
quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires
|
5 years
|
合作者和调查者
调查人员
- 学习椅：Csaba Polgár, MD, PhD, MSc、National Institute of Oncology
- 首席研究员：Norbert Mészáros, MD、National Institute of Oncology
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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