Breast Cancer Early Stage Breast Cancer (Stage 1-3)RIOMANCT07030231
Use of Intraoperative Radiotherapy in Breast Cancer
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Parc de Salut Mar at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Intraoperative
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 1 Apr 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 -
Who cannot join
- Patient's that express wish not to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma
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.
Read more
Primary objective:
To understand the characteristics of patients treated with intraoperative radiotherapy under routine clinical practice conditions.
Read the 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.
- Being tested
- Intraoperative
- Keywords
- Breast Cancer, Intraoperative radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraoperativeRadiation
Intraoperative radiotherapy with any device after conservative surgery in early breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollement to the end of recruitment at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Apr 2020
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Algara, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030231
- Sponsor's protocol ID
- SESPM-19-1
- Acronym
- RIOMA
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilización de la Radioterapia IntraOperatoria en la Neoplasia de MAma
- ClinicalTrials.gov ID
- NCT07030231
- Acronym / sponsor ID
- RIOMA / SESPM-19-1
- Keywords
- Breast Cancer, Intraoperative radiotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (1 listed)
- Patient's that express wish not to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntraoperativeIntraoperative radiotherapy with any device after conservative surgery in early breast cancer | Radiation | – |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Related trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)
RecruitingPhase 2
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrolling by invitation
Symptom Monitoring Using Patient-Report to Improve Medication Use
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Endocrine Therapy
Recruiting
Evaluation of the Effect of Regular Physical Exercise in Breast Cancer.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Not yet recruiting
PRISM Trial: Partial Breast Versus Whole Breast Radiation in Early Breast Cancer
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Breast Neoplasms, Triple Negative Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.