Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Conditions
Keywords
Breast Cancer, Intraoperative radiotherapy
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONIntraoperative
Intraoperative radiotherapy with any device after conservative surgery in early breast cancer
Sponsors
Parc de Salut Mar
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 -
Exclusion criteria
* Patient's that express wish not to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice, | 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. |
Countries
Spain
Outcome results
None listed