View Clinical Trial (Medical Research Study)
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Breast - Radiotherapy - Aesthetics - Treatment Outcome - Surgical Reconstruction |
| Purpose: |
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This study examines the aesthetic outcomes of breast reconstruction after mastectomy for
breast cancer in patients who require post-mastectomy radiation treatment. Patients will
undergo autologous tissue breast reconstruction either in immediate fashion, prior to
radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are
acceptable and are practiced clinically. this will be an observational prospective cohort
study.
The investigators hypothesize that immediate autologous reconstruction patients who undergo
subsequent radiation therapy have equivalent aesthetic outcome when compared to those in
whom reconstruction is delayed until after radiation, with the additional benefit of
avoiding the psychological side effects of breast amputation.
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| Study Summary: |
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Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer
treatment. (1, 2) Administration of radiation before or after autologous soft tissue
reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently,
the optimal timing for autologous breast reconstruction in patients who need postmastectomy
radiotherapy remains in debate between surgeons. (8) Various studies have tried to address
this problem. However, most of them have been retrospective studies (3, 7, 9) and the
prospective ones have not have enough patients, have mixed population of patients or the
radiation protocols have not been normalized. (5, 6, 10)
We hypothesize that immediate autologous reconstruction patients who undergo subsequent
radiation therapy have equivalent aesthetic outcome when compared to those in whom
reconstruction is delayed until after radiation, with the additional benefit of avoiding the
psychological side effects of breast amputation.
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| Criteria: |
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Inclusion Criteria:
- Breast cancer requiring mastectomy and post-mastectomy radiation
- Desire for breast reconstruction after mastectomy
Exclusion Criteria:
- Inflammatory breast cancer
- Age < 18 years old
- No desire for breast reconstruction
- Women without need for postmastectomy radiation
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| NCT ID: |
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NCT00845078 |
| Primary Contact: |
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Principal Investigator
Julio A Clavijo-Alvarez, MD
University of Pittsburgh
Julio A Clavijo-alvarez, MD, PhD
Phone: 412 6575588
Email: clavja@upmc.edu
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| Backup Contact: |
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Email: gimbelml@upmc.edu
Michael L Gimbel, MD
Phone: 4126615380
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Julio A Clavijo-Alvarez, MD, PhD
Phone: 412-657-5588
Email: clavja@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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