Use of Intraoperative Radiotherapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative.
- Who it may be relevant to
- Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma
Overview
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
- Radiation Intraoperative
Intraoperative radiotherapy with any device after conservative surgery in early breast cancer
Primary outcome measures
- Characteristics of patients treated with intraoperative radiotherapy according to the conditions of standard clinical practice, [Time frame: From enrollement to the end of recruitment at 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 1 center
- Hospital del Mar — Barcelona
Identifiers
NCT: NCT07030231 · SESPM-19-1