Radiation Therapy During Surgery in Treating Older Women With Stage I 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: NCT00556777
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : May 13, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: axillary lymph node dissection Procedure: conventional surgery Procedure: sentinel lymph node biopsy Radiation: intraoperative radiation therapy Phase 2

Detailed Description:



  • Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.


  • Study the impact of this regimen on maintaining self-care.
  • Study the quality of life (QLQ-C30) and satisfaction with care.
  • Study regimen tolerance and cosmetic results.
  • Evaluate the economic impact of this treatment.
  • Study relapse-free and disease-specific survival.

OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.

Patients may begin hormonal therapy after completing study therapy.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
Study Start Date : January 2004
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Feasibility
  2. Reproducibility

Secondary Outcome Measures :
  1. Quality of life (QLQ-C30)
  2. Satisfaction with care
  3. Tolerability
  4. Cosmetic results
  5. Economic impact
  6. Relapse-free survival
  7. Disease-specific survival

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


Inclusion criteria:

  • Histologically confirmed stage I breast cancer

    • Size ≤ 20 mm (by ultrasound), N0, any quadrant
  • Hormone receptor status not specified

Exclusion criteria:

  • Distant metastases
  • Inflammatory breast cancer
  • Lobular in situ disease
  • Invasive cancer or ductal carcinoma in situ
  • Nonepithelial disease or sarcoma
  • Multicentric disease
  • Lymphatic embolism
  • Margins of safety unknown or positive (in situ or invasive)
  • Preoperative mammography showing diffuse microcalcification


  • Female
  • Menopausal
  • Karnofsky 70-100%
  • No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
  • No geographic, social, or psychiatric reasons that would impede participation in study treatment


  • See Disease Characteristics
  • No prior neoadjuvant therapy
  • No concurrent participation in another study

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): NCT00556777

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Study Chair: Jean-Bernard Dubois, MD Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT00556777     History of Changes
Other Study ID Numbers: CDR0000574074
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: December 2007

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer

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