Clinical trial · Observational
Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer
A Prospective Observational Trial of Xoft® Intraoperative Radiotherapy (IORT) as a Component of Breast Conserving Therapy (BCT) in Patients With Early-Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.
Conditions
Conditions (5)
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 |
| Breast Cancer, Invasive Ductal | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IIA | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Invasive Mammary Carcinoma | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients with greater than or equal to grade 2 acute radiation toxicities
- timeFrame
- within 6 months of radiotherapy
- description
- Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0
Secondary outcomes (3)
- measure
- Percentage of patients with greater than or equal to grade 2 late radiation toxicities
- timeFrame
- starting three months after radiation and continuing for 5 years
- description
- Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0
- measure
- Percentage of patients with good or excellent cosmetic outcome as assessed by the Harvard cosmesis scale
- timeFrame
- starting immediately after radiation and continuing for 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery * Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node * Tumors 2.5 cm or less in size (clinical preoperative staging) * Estrogen receptor positive tumors (≥10%) * Her2 negative/not over-expressed * Patients 50 years of age or greater Exclusion Criteria: * Prior malignancy not in remission * Active collagen vascular disease requiring active cytotoxic or immunotherapy * Psychiatric or mental condition which would preclude informed consent * Prior thoracic radiation which overlaps with IORT field * Pregnant patients * Patients \<50 years * Risk of positive sentinel lymph node \>20% based on nomogram estimates * Known lymph node metastases (i.e. clinically node positive) * Patients with invasive lobular carcinoma * Patients with pure DCIS * Known multifocal or multicentric tumor * Patients requiring neoadjuvant chemotherapy * Patients requiring or choosing mastectomy with or without reconstruction * Technical contraindications to IORT dose delivery including skin to balloon distance \<7 mm * Medical contraindication to IORT, radiation or breast conservation
References
Publications (0)
Data not yet available