Clinical trial · Observational
Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma in Situ | Breast Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiation Therapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IORT
- description
- All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.
- interventionNames
- Radiation: Intraoperative Radiation Therapy (IORT)
Primary outcomes (1)
- measure
- Disease Recurrence
- timeFrame
- 5 years
- description
- Presence of recurrent tumor in ipsilateral breast or distant site
Secondary outcomes (2)
- measure
- Disease specific survival
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification) * Unifocal Disease * Candidate for breast-conserving surgery * Recommended treatment by multidisciplinary team Exclusion Criteria: * Clinical stage T3-4, N1-3, M1 * Multifocal disease
References
Publications (0)
Data not yet available