Clinical trial · Interventional
Intra-operative Radiotherapy For Breast Cancer Women After NSM
Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
NCT02389686CI-TRIAL-00017143unknownN/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)
The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INTRABEAM (Carl Zeiss, Oberkochen, Germany) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Without Radiotherapy
- description
- Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
- type
- EXPERIMENTAL
- label
- Intraoperative Radiotherapy
- description
- Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).
- interventionNames
- Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Primary outcomes (1)
- measure
- Ipsilateral breast tumor recurrence rate after surgery within five years
- timeFrame
- Within 5 years after surgery
- description
- Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor diameter ≤3 cm * Tumor from the papilla\>2cm * Low grade ductal carcinoma in situ * Candidate for breast-conserving surgery * Must have undergone lumpectomy with negative margins or minimal margin involvement * Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection * No evidence of metastatic disease * Informed consent Exclusion Criteria: * No informed consent * Tumor size \> 3 cm * Tumor from the papilla≤2cm * Intermediate or high grade ductal carcinoma in situ * Invasive carcinoma * No indication for a boost
References
Publications (0)
Data not yet available
No reference posted for this study.