Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II 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: NCT00647582
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 21, 2018
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

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.

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

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
Study Start Date : October 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : December 21, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Feasibility
  2. Acute tolerability
  3. Local tumor control rate
  4. Distant tumor control rate
  5. Long-term side effects
  6. Cosmetic outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No prior irradiation to the area of planned radiation field
  • Concurrent hormone therapy 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): NCT00647582

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: NCT00647582     History of Changes
Other Study ID Numbers: CDR0000588774
P30CA015083 ( U.S. NIH Grant/Contract )
MCS066 ( Other Identifier: Mayo Clinic Cancer Center )
1681-02 ( Other Identifier: Mayo Clinic IRB )
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: April 2016

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