Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602108
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : August 10, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: adjuvant therapy Procedure: conventional surgery Radiation: hypofractionated radiation therapy Radiation: intraoperative radiation therapy Phase 2

Detailed Description:


  • To determine the feasibility and acute patient tolerance of intraoperative electron irradiation (IOERT) and hypofractionated external-beam irradiation (HYPORT) after lumpectomy for patients with stage I-IIA breast cancer treated with breast conservation therapy.
  • To determine the local tumor control and distant tumor control rates for patients with stage I-IIA breast cancer treated with breast conservation therapy using IOERT and HYPORT after lumpectomy.
  • To determine the long-term side effects and cosmetic outcome of IOERT to tumor bed and HYPORT after lumpectomy for patients with stage I-IIA breast cancer.

OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo intraoperative electron irradiation (IOERT) to the tumor bed right after completion of lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.

Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily for 16 days.

After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter for 8 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
Study Start Date : January 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Toxicity: Up to 3 months post external beam radiation therapy [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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 allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00602108

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: William W. Wong, MD Mayo Clinic

Responsible Party: William Wailing Wong, M.D., Mayo Clinic Cancer Center Identifier: NCT00602108     History of Changes
Other Study ID Numbers: CDR0000583007
P30CA015083 ( U.S. NIH Grant/Contract )
MCS314 ( Other Identifier: Mayo Clinic Cancer Center )
806-04 ( Other Identifier: Mayo Clinic IRB )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Mayo Clinic:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases