Use of Intraoperative Radiotherapy in Breast Cancer

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.

NCT Number	NCT07030231
Lead Sponsor	Parc de Salut Mar
Conditions	Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment	3,000 participants
Start Date	2020-04-01
Primary Completion	2030-04-01 (estimated)
Study Completion	2031-04-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-31