Clinical trial · Interventional
Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
- 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 study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding breast tissue is at greater risk for developing breast recurrences. This treatment may be as effective as the conventional 5-6week radiation treatment in reducing the risk of further local recurrences after breast-conserving surgery. Through this study, we would like to confirm that this procedure is a safe alternative to conventional breast radiation, with no additional side effects when compared with the conventional surgery and radiation therapy.
Conditions
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra Operative Radiation Therapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Radiation: Intra Operative Radiation Therapy (IORT)
Primary outcomes (2)
- measure
- To determine tissue tolerance of the breast to a single intraoperative course of radiation.
- timeFrame
- 7 years
- measure
- To establish feasibility of the technique in the operating room.
- timeFrame
- 7 years
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- 7 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Core biopsy or prior open biopsy to establish the diagnosis. * Over age 60. * No physical or imaging evidence of multicentricity or multifocality. * Size equal or less than 2.0 cm radiographically, clinically node negative. * Patients scheduled for breast conserving surgery Exclusion Criteria: * Patients younger than 61 years * Patients with evidence of multicentric or multifocal disease seen on imaging (mammography ) * Patients with a lesion exceeding 2 cm radiographically * Paget's disease or pure DCIS without invasive ductal carcinoma * Histotype not inclusive of ductal carcinoma * Condition precluding radiation therapy * Condition precluding regular follow-up * Evident dimpling of the skin above the tumor * Usual contraindications for BCS
References
Publications (0)
Data not yet available