Multicatheter interstitial brachytherapy (MIBT) based accelerated partial breast irradiation (APBI) - dosimetric comparison with external beam radiotherapy and report on early outcomes in terms of toxicity and local control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To dosimetrically compare normal tissue exposure and tumor coverage of IMRT among patients treated with MIBT based APBI
研究概览
简要总结
Radiation therapy (RT) is an integral component of local therapy following breast conservation surgery in patients with breast carcinomas. It is typically delivered to the Whole breast by teletherapy techniques ranging from conventional to Intensity Modulated RT (IMRT). The conventionally fractionated whole breast RT treatment regimen usually takes six weeks to complete. More recent hypofractionated EBRT schedules have managed to reduce the overall treatment time, but it still takes at least 3 weeks for the entire course treatment.
A relatively new technique called Accelerated partial breast irradiation (APBI) is becoming widely accepted among the radiation oncologists treating breast cancer as well as the patients. The rationale behind APBI is that most of the local recurrences develop in close proximity to tumour bed; therefore, treating only the vicinity of resection cavity could potentially provide for equivalent local control rates, while simultaneously reducing toxicity by lowering the overall irradiated volumes. Small treatment volumes also enable larger fractional dose, thereby drastically reducing overall treatment time to less than 1 week.
There is now evidence to suggest that APBI is a suitable alternative to WBRT for selected patients.(10,11)There are different approaches to APBI like Multicatheter interstitial brachytherapy (MIBT), Single/multichannel balloon and hybrid device brachytherapy (BT) and EBRT techniques such as 3D-Conformal RT (3D-CRT), IMRT, Volume modulated arc therapy (VMAT) and proton therapy (3, 4). There are research works clinically and/or dosimetrically comparing between various APBI techniques and with WBI. (5-8) This study plans to retrospectively compare the tumor coverage, and normal tissue exposure with IMRT in patients treated with MIBT at our center and to report on early outcomes in terms of toxicity and local control.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients eligible and willing to undergo APBI.
- •The American Society for Radiation Oncology (ASTRO) recommendations for APBI include all of the following:
- •Age > 50 years
- •Tumor ≤ 3 cm
- •Histology: IDC Invasive Ductal Carcinoma
- •Negative Lymph node status
- •Negative resection margins
- •No evidence of Lympho-vascular invasion
- •No evidence of Extracapsular invasion
- •In addition, patients with features considered to be cautionary by guidelines (such as ages between 40-50 years, high grade disease, evidence of LVSI, etc.) who have been informed about the pros and cons of APBI and have voluntarily preferred undergoing the procedure will be taken up.
排除标准
- •Patients unwilling for APBI
- •Positive surgical resection margins.
- •Other definite contraindications for APBI such as multiple nodes positive, neoadjuvant chemotherapy, multifocal/multicentric disease, etc.
- •Incomplete/inadequate information on relevant Organs at Risk on Planning CT images.
- •Patients in whom the implant was deemed as unacceptable (eg: gross miss of surgical cavity).
结局指标
主要结局
To dosimetrically compare normal tissue exposure and tumor coverage of IMRT among patients treated with MIBT based APBI
时间窗: 3 months from ethics committee clearance
次要结局
- 1. To evaluate local control rate following MIBT-APBI(2. To analyse toxicities of treatment)