NCT07030231

Use of Intraoperative Radiotherapy in Breast Cancer

Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

Type	Name	Description
RADIATION	Intraoperative	Intraoperative radiotherapy with any device after conservative surgery in early breast cancer

Timeline

• Start date: 2020-04-01
• Primary completion: 2030-04-01
• Completion: 2031-04-01
• First posted: 2025-06-22
• Last updated: 2025-07-31

Locations

1 site across 1 country: Spain