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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647582

Enrollment

Registered

2008-03-31

Start date

2002-10-31

Completion date

2013-12-21

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

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.

Detailed description

OBJECTIVES: * To determine the feasibility and acute tolerability of intraoperative electron radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women with stage I or II breast cancer treated with breast conservation therapy. * To determine the local tumor control and distant tumor control rates in these patients. * To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed and EBRT after lumpectomy in these patients. OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions. After completion of study treatment, patients are followed periodically for up to 8 years.

Interventions

PROCEDUREadjuvant therapy

PROCEDUREtherapeutic conventional surgery

RADIATIONintraoperative radiation therapy

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

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 allowed

Design outcomes

Primary

Measure	Time frame
Feasibility	—
Acute tolerability	—
Local tumor control rate	—
Distant tumor control rate	—
Long-term side effects	—
Cosmetic outcome	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026