Mammosite Breast Brachytherapy Optimization in the Treatment of Breast Carcinoma (Mammosite)
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|ClinicalTrials.gov Identifier: NCT00611624|
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Radiation: Mammosite brachytherapy radiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Mammosite Breast Brachytherapy Optimization in the Treatment of Stage 0, I and II Breast Carcinoma|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: Five Days of Mammosite Therapy
Five Days of Mammosite Therapy (Radiotherapy)
Radiation: Mammosite brachytherapy radiation
Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.
- Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method. [ Time Frame: one year ]Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.
- Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity [ Time Frame: Upon completion of study ]These data were not collected and were not summarized in this study. Results are not available.
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): NCT00611624
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Joanne Weidhaas, M.D., Ph.D.||Yale University|