Clinical trial · Interventional
Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
Phase II Study of Intra-operative Electron Irradiation and 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 radiation therapy during and after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II 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 |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Feasibility
- measure
- Acute tolerability
- measure
- Local tumor control rate
- measure
- Distant tumor control rate
- measure
- Long-term side effects
- measure
- Cosmetic outcome
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary invasive breast carcinoma, meeting the following criteria:
* Stage I or II disease (T1-T2, N0, M0)
* Tumor pathologically determined to be ≤ 5 cm in diameter
* Single, discrete, well-defined primary tumor
* No multicentric disease and/or diffuse malignant appearing microcalcifications
* Any microcalcifications must be focal
* Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications
* No axillary lymph node involvement
* Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling
* Must have pathologically negative surgical margins
* No evidence of metastatic breast cancer
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy
PRIOR CONCURRENT THERAPY:
* No prior irradiation to the area of planned radiation field
* Concurrent hormone therapy allowedReferences
Publications (0)
Data not yet available