Clinical trial · Interventional
Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer
Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well radiation therapy works in treating women undergoing lumpectomy for stage I or stage IIA 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity: Up to 3 months post external beam radiation therapy
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary invasive breast carcinoma
* Stage I-IIA disease (T1, N0, M0 or T2, N0, M0)
* Pathologically determined single, discrete, and well-defined primary tumor ≤ 5 cm in diameter
* Pathologically negative surgical margins
* No multicentric disease and/or diffuse malignant appearing microcalcifications
* Micro-calcifications must be focal
* Specimen radiograph is required after lumpectomy for tumors associated with malignant appearing calcifications to assure removal of all malignant appearing calcifications
* Specimen radiograph is optional if the tumor appears as a discrete mass on mammogram
* No axillary lymph node involvement
* No evidence of metastatic breast cancer
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Menopausal status not specified
* No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* No prior irradiation to the area of planned radiation field
* No prior placement of breast prosthesis in the treated breast
* Concurrent hormonal therapy with external-beam irradiation allowedReferences
Publications (0)
Data not yet available