NCT Number: NCT00104702
Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer
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 studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.
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Notify MeKey information
Conditions
Age range
70 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
Institut Bergonie, Bordeaux, France
About this study
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.
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
conventional surgery
Procedureradiation therapy
RadiationPrimary outcomes
-
Reproducibility
Time frame: 1 month
Secondary outcomes
-
Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score
Time frame: 3 weeks
-
Relapse-free survival
Time frame: 1 year
-
Overall and specific survival
Time frame: 1 year
-
Cosmetic result
Time frame: 1 year
-
Direct and indirect costs
Time frame: 1 month
Sponsors and collaborators
Lead sponsor
UNICANCER
Other
Registry information
Official study title
Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
Acronym: GERICO03
Important dates
- Study start
- 2004
- Primary completion
- 2008
- Study completion
- 2011
- First posted
- Mar 4, 2005
- Registry last updated
- Sep 4, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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