Use of Intraoperative Radiotherapy in Breast Cancer

NCT07030231 | Enrolling By Invitation

• 1 other identifier: SESPM-19-1
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast Cancer; Intraoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

• Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice,

  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.

  From enrollement to the end of recruitment at 10 years

Interventions

Intraoperative RADIATION

Intraoperative radiotherapy with any device after conservative surgery in early breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early breast cancer who are candidates for intraoperative radiotherapy, such as exclusive partial irradiation, anticipated boosting, or salvage after a second conservative surgery.

You may qualify if:

• 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 -

You may not qualify if:

• Patient's that express wish not to participate.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: April 1, 2020
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

ES (1)