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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- late radiation side-effect
研究概览
简要总结
The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.
详细描述
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+
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
late radiation side-effect
时间窗: 5 years
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
次要结局
- local tumor control(5 years)
- overall survival(5 years)
- regional tumor control(5 years)
- cosmetic results(5 years)
- cancer specific survival(5 years)
- disease free survival(5 years)
研究者
Csaba Polgár
Professor
National Institute of Oncology, Hungary