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Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00556777
First received: November 9, 2007
Last updated: May 12, 2011
Last verified: December 2007
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Procedure: axillary lymph node dissection
Procedure: conventional surgery
Procedure: sentinel lymph node biopsy
Radiation: intraoperative radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Reproducibility [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (QLQ-C30) [ Designated as safety issue: No ]
  • Satisfaction with care [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Cosmetic results [ Designated as safety issue: No ]
  • Economic impact [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: January 2004
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior neoadjuvant therapy
  • No concurrent participation in another study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556777

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Study Chair: Jean-Bernard Dubois, MD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00556777     History of Changes
Other Study ID Numbers: CDR0000574074, CLCC-IORT-Sein, INCA-RECF0284
Study First Received: November 9, 2007
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 21, 2013