Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Technique of Per-Operative Radiotherapy feasability
研究概览
简要总结
Phase 1/2 study, open, monocenter, non-randomized
详细描述
Breast cancer, like the majority of cancers, has an incidence wich increased with age. Breast cancer in elderly women from an age of more than 70 years is defined but even from the age of 60, a simplified conservative treatment appears to be of interest, It is reserved for well selected tumors, small sizes, with low risk of local relapse.
In practice, the ratio of tumor to breast volume optimizes the selection of patients who can benefit from conservative treatment.
Standard conservative treatment is represented by tumorectomy (with axillary or sentinel lymph node) associated with irradiation of the entire breast. A dose of 60 Grays in 6 weeks is considered as standard.
To reduce radiation therapy, accelerated partial irradiation of the breast (IPAS) is a widely explored research pathway with several technical options. Among these IPAS techniques, per-operative radiotherapy (RPO) is an alternative that can be performed by various techniques: electrontherapy or by X-rays of 50 Kv, or even by MammositeTM or interstitial brachytherapy but in this case with an irradiation carried out at a distance from the intervention which has been used to set up the vectors to carry out this irradiation secondarily.
Currently, 7 randomized trials tested the results of IPAS, including 2 in perioperative ELIOT (Electron Intraoperative therapy) and TARGIT A (Targeted intraoperative radiotherapy.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with grade 1 or 2 invasive ductal adenocarcinoma or ductal carcinoma in situ, regardless of grade (found on mammography by an outbreak of Single microcalcification with a diameter not exceeding 2 cm or a tumor opacity <2 cm),
- •Patient aged 60 years or older (patients 60 years of age in the year may be included);
- •Unilateral adenocarcinoma, unifocal, positive HR, non-overexpressed HER-2 - T1 N0 radio-clinical , Operable patient with breast volume compatible with conservative surgery,
- •Patients who have been made aware of the information sheet and have given their written signed informed consent.
- •Patients benefitting from social health insurance coverage.
排除标准
- •Age less than 60 years
- •Patient with grade 3 invasive breast carcinoma
- •Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
- •Metastatic patient
- •Multifocal and / or bilateral tumor
- •N1 proved by ultrasound guided
- •Patient with psychological and / or psychiatric disorders
- •Vulnerable patient: a person deprived of liberty by an administrative or judicial decision, a major person who is the object of a legal protection measure or is unable to express his / her consent
研究组 & 干预措施
Per-Operative Radiotherapy
Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM
干预措施: Papillon +TM (Device)
结局指标
主要结局
Technique of Per-Operative Radiotherapy feasability
时间窗: up to 3 years
To evaluate the feasibility of performing an RPO delivering a satisfactory dose in the tumor excision bed measured using an in vivo dosimetry
次要结局
- Procedure tolerance(up to 3 years)
- Survival without local recurrence(up to 3 years)
- Application quality(up to 3 years)