Clinical trial · Interventional
Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
NCT02040493CI-TRIAL-00028770terminatedN/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 is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.
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
- Intra-operative radiation therapy (IORT)
- description
- IORT
- interventionNames
- Radiation: Intra-operative radiation therapy (IORT)
Primary outcomes (2)
- measure
- Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.
- timeFrame
- 5 Years
- description
- Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
- measure
- Occurence of serious adverse events during and following IORT treatment.
- timeFrame
- 5 Years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
General Inclusion Criteria 1. Age \> 45 years 2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification) 3. Invasive ductal carcinoma and / or DCIS Intra-operative Inclusion Criteria 1. Negative sentinel node assessment 2. Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound Post procedure Inclusion Criteria 1. Negative microscopic surgical margins\*\* \*\*If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis. General Exclusion Criteria 1. Scleroderma, systemic sclerosis and active lupus 2. Participation in an investigational drug or device study 3. Previous ipsilateral radiation to the thorax or breast Intra-operative Exclusion Criteria 1. Intra-operative positive sentinel lymph node biopsy 2. Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image) 3. Skin spacing less than 1-cm via intraOp ultrasound. 4. A cavity size that is not appropriate for a 40 -70 cc balloon. 5. Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.