Clinical trial · Interventional
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
NCT01960803CI-TRIAL-00081336withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IOERT is no longer an experimental treatment and was now offered as SOC to patients experiencing IBC. As this therapy is being offered to them regardless of study participation at numerous institutions across the country.
Summary
Brief summary (as posted)
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Breast Stage I | — | UNRESOLVED | — |
| Invasive Ductal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Electron Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IOERT arm
- description
- Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.
- interventionNames
- Radiation: Intraoperative Electron Radiotherapy
Primary outcomes (1)
- measure
- To evaluate change over time on the incidence of local and distance recurrence rates.
- timeFrame
- 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
- description
- Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer * Patient agrees to evaluation of the axilla with sentinel lymph node biopsy * Peri or post-menopausal women age \> 50, defined as women who have experienced no menstrual period in the past 6 months or more * BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\] * Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria) * Grade 1, 2, or 3 acceptable * Associated LCIS is allowed * Pure DCIS allowed if \<2.5 cm, low to intermediate nuclear grade and resected margins negative at \> 3 mm (per ASTRO criteria) * Estrogen receptor (ER) status of positive * Patient has clear margins \>2 mm on gross pathologic examination * Patient is node-negative, defined as N0 (i-) or N0 (i+) * Patient must be deemed functionally and mentally competent to understand and sign the informed consent * Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy Exclusion Criteria: * Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years * Immunocompromised status * Pregnancy * Women with an active connective tissue disorder (i.e. scleroderma, lupus and others) * Breast cancer that involves the skin or chest wall, locally advanced breast cancer * Invasive lobular carcinoma * Evidence of lymphovascular invasion (LVI) * Invasive carcinoma with extensive intraductal component (EIC) * Neoadjuvant chemotherapy * Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection * Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.