Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 23
- 主要终点
- Five-year incidence of late grade ≥ 2 side effects
研究概览
简要总结
To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
详细描述
Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy & Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome.
Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely.
A phase II multicenter trial is proposed to confirm this hypothesis.
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
- •Stage 0 & I & II (< 3 cm) breast carcinoma
- •Lesions of < 3 cm diameter
- •Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
- •Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)
- •M0: Absence of distant metastasis
- •Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)
- •Unifocal (multifocality limited within 2 cm) and unicentric breast cancer
- •Age> 40 years
- •Luminal A or B tumors
- •Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks
- •Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy
- •Specific signed consent form prior to randomization
排除标准
- •Stage III-IV breast cancer
- •Surgical margins that cannot be microscopically assessed
- •Extensive intraductal component (EIC+)
- •Extensive lymphovascular invasion (LVI+) (focal is allowed)
- •Triple negative breast cancer
- •BReast CAncer gene (BRCA) 1-2 mutation
- •Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy
- •Neoadjuvant systemic therapy
- •Paget's disease or pathological skin involvement
- •Synchronous or previous breast cancer.
- •Pregnant or lactating women
研究组 & 干预措施
single-fraction very accelerated partial breast irradiation arm
Low risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy.
干预措施: single-fraction very accelerated partial breast irradiation (Radiation)
结局指标
主要结局
Five-year incidence of late grade ≥ 2 side effects
时间窗: From the third month of treatment to the end of the fifth year of follow-up.
Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).
次要结局
- Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of regional relapse (RR)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of distant metastasis (DM)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS)(From treatment to the end of the fifth year of follow-up.)
- Incidence (5-year actuarial rate) of death by any cause for overall survival (OS)(From treatment to the end of the fifth year of follow-up.)
- Incidence of acute side effects(From treatment to the end of the first 3 months of follow-up.)
- Cosmetic results at 5 years(From treatment to the end of the fifth year of follow-up.)
- Quality of Life (QoL)(From treatment to the end of the fifth year of follow-up.)
研究者
Viktor Smanykó, MD, PhD
chief physician
National Institute of Oncology, Hungary