Clinical trial · Interventional
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue
NCT00182728CI-TRIAL-00081183NRRcompletedN/AResults postedClinicalTrials.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 radiation during surgery may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Radiation Arm
- description
- Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
- interventionNames
- Procedure: surgery
- Procedure: therapy
- Radiation: radiation therapy
Primary outcomes (4)
- measure
- Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician
- timeFrame
- 1 year follow up visit
- description
- Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 48 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive ductal carcinoma of the breast * Tumor size ≤ 3 cm * No extensive intraductal component * Tumor must not be attached to the skin, underlying muscle, or chest wall * Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist * Tumor amenable to segmental mastectomy (i.e., lumpectomy) * No bilateral breast cancer * No clinical or radiographic multifocal disease not amenable to single segmental mastectomy * Patients with \> 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 48 and over Sex * Female Menopausal status * Not specified Performance status * 0-2 Life expectancy * At least 5 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant * Fertile patients must use effective contraception * No collagen vascular disease * No medical condition that would preclude surgery * Other prior malignancy allowed provided the following criteria are met: * Patient has undergone potential curative therapy for all prior malignancies * There is no evidence of any prior malignancy within the past 5 years * Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for this malignancy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the breast Surgery * No breast implants
References
Publications (5)
- BACKGROUNDOllila DW, Klauber-DeMore N, Tesche LJ, Kuzmiak CM, Pavic D, Goyal LK, Lian J, Chang S, Livasy CA, Sherron RF, Sartor CI. Feasibility of breast preserving therapy with single fraction in situ radiotherapy delivered intraoperatively. Ann Surg Oncol. 2007 Feb;14(2):660-9. doi: 10.1245/s10434-006-9154-1. PMID 17091330
- BACKGROUNDStitzenberg KB, Klauber-Demore N, Chang XS, Calvo BF, Ollila DW, Goyal LK, Meyers MO, Kim HJ, Tepper JE, Sartor CI. In vivo intraoperative radiotherapy: a novel approach to radiotherapy for early stage breast cancer. Ann Surg Oncol. 2007 Apr;14(4):1515-6. doi: 10.1245/s10434-006-9152-3. PMID 17235715
- RESULTKimple RJ, Klauber-DeMore N, Kuzmiak CM, Pavic D, Lian J, Livasy CA, Chiu WM, Moore DT, Sartor CI, Ollila DW. Local control following single-dose intraoperative radiotherapy prior to surgical excision of early-stage breast cancer. Ann Surg Oncol. 2011 Apr;18(4):939-45. doi: 10.1245/s10434-010-1392-6. PMID 21061074
- RESULTVanderwalde NA, Jones EL, Kimple RJ, Moore DT, Klauber-Demore N, Sartor CI, Ollila DW. Phase 2 study of pre-excision single-dose intraoperative radiation therapy for early-stage breast cancers: six-year update with application of the ASTRO accelerated partial breast irradiation consensus statement criteria. Cancer. 2013 May 1;119(9):1736-43. doi: 10.1002/cncr.27915. Epub 2013 Jan 29. PMID 23361892
- RESULTKimple RJ, Klauber-DeMore N, Kuzmiak CM, Pavic D, Lian J, Livasy CA, Esler L, Moore DT, Sartor CI, Ollila DW. Cosmetic outcomes for accelerated partial breast irradiation before surgical excision of early-stage breast cancer using single-dose intraoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):400-7. doi: 10.1016/j.ijrobp.2009.10.032. Epub 2010 Apr 13. PMID 20395062