Status:

COMPLETED

Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer

Lead Sponsor:

UNICANCER

Conditions:

Breast Cancer

Eligibility:

FEMALE

70+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is st...

Detailed Description

OBJECTIVES: Primary * Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of invasive breast cancer
  • Stage I or II disease
  • Tumor size ≤ 30 mm
  • Located in any breast quadrant
  • No nodal involvement
  • No inflammatory breast cancer
  • No positive margins after surgical resection (performed on study)
  • No microcalcifications
  • Hormone receptor status
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • Over 70
  • Sex
  • Female
  • Menopausal status
  • Not specified
  • Performance status
  • Karnofsky 70-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2011

    Estimated Enrollment :

    46 Patients enrolled

    Trial Details

    Trial ID

    NCT00104702

    Start Date

    July 1 2004

    End Date

    March 1 2011

    Last Update

    September 4 2013

    Active Locations (10)

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    Page 1 of 3 (10 locations)

    1

    Institut Bergonie

    Bordeaux, France, 33076

    2

    Centre Oscar Lambret

    Lille, France, 59020

    3

    Centre Leon Berard

    Lyon, France, 69373

    4

    Centre Antoine Lacassagne

    Nice, France, 06088