Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer
NCT ID: NCT00104702
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2004-07-31
2011-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.
Detailed Description
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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.
Secondary
* Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients.
* Determine relapse-free survival of patients treated with this regimen.
* Determine overall and specific survival of patients treated with this regimen.
* Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients.
* Determine the direct and indirect costs of this regimen in these patients.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Concentrated and Focalized Radiotherapy
adjuvant therapy
conventional surgery
radiation therapy
Interventions
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adjuvant therapy
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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J. M. Hannoun-Levi, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Antoine Lacassagne
Locations
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Institut Bergonie
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Saint-Louis
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Paul Strauss
Strasbourg, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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FRE-FNCLCC-GERICO-03/0303
Identifier Type: -
Identifier Source: secondary_id
EU-20501
Identifier Type: -
Identifier Source: secondary_id
CDR0000416123
Identifier Type: -
Identifier Source: org_study_id