Clinical trial · Interventional
Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer
Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
NCT00556777CI-TRIAL-00086862IORT-SeincompletedN/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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I 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 |
|---|---|---|---|
| axillary lymph node dissection | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- breast conserving surgery with lymph node dissection + Intraoperative radiotherapy
- interventionNames
- Procedure: axillary lymph node dissection
- Procedure: conventional surgery
- Procedure: sentinel lymph node biopsy
- Radiation: intraoperative radiation therapy
Primary outcomes (2)
- measure
- Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
- timeFrame
- During the treatment of irradiation (4 weeks)
- description
- feasibility based on dosimetric criteria based on the Quality Index of the application.
- measure
- Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed stage I breast cancer * Size ≤ 20 mm (by ultrasound), N0, any quadrant * Hormone receptor status not specified Exclusion criteria: * Distant metastases * Inflammatory breast cancer * Lobular in situ disease * Invasive cancer or ductal carcinoma in situ * Nonepithelial disease or sarcoma * Multicentric disease * Lymphatic embolism * Margins of safety unknown or positive (in situ or invasive) * Preoperative mammography showing diffuse microcalcification PATIENT CHARACTERISTICS: * Female * Menopausal * Karnofsky 70-100% * No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years * No geographic, social, or psychiatric reasons that would impede participation in study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior neoadjuvant therapy * No concurrent participation in another study
References
Publications (67)
- BACKGROUNDAaronson NK. Assessing the quality of life of patients in cancer clinical trials: Common problems and common sense solutions. Eur J Cancer. 1992;28A(8-9):1304-7. doi: 10.1016/0959-8049(92)90504-u. No abstract available. PMID 1515238
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDNattinger AB, Kneusel RT, Hoffmann RG, Gilligan MA. Relationship of distance from a radiotherapy facility and initial breast cancer treatment. J Natl Cancer Inst. 2001 Sep 5;93(17):1344-6. doi: 10.1093/jnci/93.17.1344. No abstract available. PMID 11535710
- BACKGROUNDArnulf G. Lymphoedema of the upper limb after Halsted's operation of radical mastectomy.. Lymphography and phlebography. Therapeutic consequences. Vasc Surg. 1973 Jan-Feb;7(1):36-44. doi: 10.1177/153857447300700105. No abstract available. PMID 4691036
- BACKGROUNDArriagada R, Le MG, Rochard F, Contesso G. Conservative treatment versus mastectomy in early breast cancer: patterns of failure with 15 years of follow-up data. Institut Gustave-Roussy Breast Cancer Group. J Clin Oncol. 1996 May;14(5):1558-64. doi: 10.1200/JCO.1996.14.5.1558. PMID 8622072
- BACKGROUNDBalducci L, Extermann M, Carreca I. Management of breast cancer in the older woman. Cancer Control. 2001 Sep-Oct;8(5):431-41. doi: 10.1177/107327480100800507. PMID 11579340
- BACKGROUNDBalducci L, Lyman GH. Cancer in the elderly. Epidemiologic and clinical implications. Clin Geriatr Med. 1997 Feb;13(1):1-14.