Clinical trial · Interventional
Single Fraction Intraoperative Radiotherapy
Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial
NCT01688388CI-TRIAL-00058418completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Ductal and Invasive Lobular Breast Carcinoma | Invasive Breast Ductal Carcinoma and Invasive Lobular Carcinoma | ALIAS | 0.90 |
| Stage 0 Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IORT Arm
- description
- Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
- interventionNames
- Procedure: Intraoperative Radiotherapy
Primary outcomes (1)
- measure
- Toxicity Assessment
- timeFrame
- 5 years
- description
- Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system: * End of initial surgical phase: Week 1, 4 * First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
Secondary outcomes (2)
- measure
- Cosmetic Evaluation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 41 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ * Age \> 40 years * Karnofsky performance status \> 70% * Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm * Nodal Status: preoperatively N0 * Clear surgical margins: R0 * All grades G1 - G3 * Any hormonal receptor and HER-2 status * Informed consent Exclusion Criteria: * Gender: male * Tumor size: more than 2.5 cm * Nodal status greater than or equal to N1 pathologically * Multicentricity * Previous radiotherapy to the involved breast * Karnofsky Index \< 70% * Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus * Distant metastases * Pregnancy in woman of child bearing age * Unable to provide written consent
References
Publications (0)
Data not yet available
No reference posted for this study.