Clinical trial · Interventional
Intraoperative Radiation Therapy in Early Stage Breast Cancer
Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
NCT02266602CI-TRIAL-00038337IORTBreastcompletedN/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)
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage 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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
- interventionNames
- Radiation: Intraoperative Radiation Therapy
Primary outcomes (1)
- measure
- Local Disease Relapse
- timeFrame
- 10 years
- description
- Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
Secondary outcomes (1)
- measure
- Disease specific and overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: General Inclusion Criteria 1. Age ≥ 45 years. 2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification). 3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ. 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. 4. Multifocal breast cancer. 5. Pregnant patients. 6. Patient not competent to provide informed consent. 7. Neoadjuvant systemic therapy. 8. Lymphovascular invasion on biopsy pathology
References
Publications (0)
Data not yet available
No reference posted for this study.