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

January 23, 2008
January 28, 2008
August 10, 2011
January 2005
August 2007   (Final data collection date for primary outcome measure)
Toxicity: Up to 3 months post external beam radiation therapy [ Time Frame: 3 months ]
  • Acute patient tolerance
  • Local tumor control rate
  • Distant tumor control rate
  • Long-term side effects
  • Cosmetic outcome
  • Disease-free survival
  • Overall survival
  • Toxicity
Complete list of historical versions of study NCT00602108 on Archive Site
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Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer
Phase II Study of Intra-operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer

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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Radiation: hypofractionated radiation therapy
  • Radiation: intraoperative radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2007
August 2007   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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P30CA015083 ( U.S. NIH Grant/Contract )
MCS314 ( Other Identifier: Mayo Clinic Cancer Center )
806-04 ( Other Identifier: Mayo Clinic IRB )
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William Wailing Wong, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: William W. Wong, MD Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP