Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice,
研究概览
简要总结
The Utility of Intraoperative Radiotherapy in Breast Cancer (RIOMA) is an observational project to understand the use and outcomes of intraoperative radiotherapy in patients with breast cancer under conditions of clinical use (not clinical trials). Intraoperative radiotherapy (IORT) is a technique that began to be used years ago, transferring the patient from the operating room to the radiotherapy suite. This technique therefore fell into disuse. The emergence of miniaturized linear accelerators has led to a resurgence of IORT, especially as part of conservative treatment in patients with breast cancer, both as a booster or as a sole treatment (partial breast irradiation).
This project is based on an online platform. Each participating center will be assigned access codes on the website to access and complete the coded clinical data for each patient treated with intraoperative radiotherapy. Data on tumor characteristics, the type of intraoperative radiotherapy, follow-up, complications, and cosmetic outcomes are included.
Primary objective:
To understand the characteristics of patients treated with intraoperative radiotherapy under routine clinical practice conditions.
详细描述
The project is based on structured data collection in an electronic data collection notebook (using the OpenclinicaTM standard), relating to the care provided according to standard clinical practice in the Radiation Oncology, Gynecology and Surgery departments of the participating centers in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer who are candidates for intraoperative irradiation exclusively
- •Patients with breast cancer who are candidates for intraoperative irradiation combined with external beam irradiation
- •Patients with recurrence of breast cancer who are candidates for intraoperative irradiation
- •Have read the information sheet and signed the informed consent form -
排除标准
- •Patient's that express wish not to participate.
结局指标
主要结局
Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice,
时间窗: From enrollement to the end of recruitment at 10 years
To evaluate the characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice, retrospectively from the beginning of the implementation of the technique and prospectively from the launch of this registry.
次要结局
未报告次要终点
研究者
Manuel Algara
Principal Investigator
Parc de Salut Mar