Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00556777|
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : May 13, 2011
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|
- 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|
|Masking:||None (Open Label)|
|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|
- Quality of life (QLQ-C30)
- Satisfaction with care
- Cosmetic results
- Economic impact
- Relapse-free survival
- Disease-specific survival
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 ClinicalTrials.gov identifier (NCT number): NCT00556777
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Jean-Bernard Dubois, MD||Institut du Cancer de Montpellier - Val d'Aurelle|