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The purpose of this study is to determine if Mammosite Catheter optimization using multiple dwell position delivery decreases skin toxicity over historically reported skin toxicity with the single dwell delivery method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Five Days of Mammosite Therapy | Experimental | Five Days of Mammosite Therapy (Radiotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mammosite brachytherapy radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method. | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity | These data were not collected and were not summarized in this study. Results are not available. | Upon completion of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Weidhaas, M.D., Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Five Days of Mammosite Therapy | Five Days of Mammosite Therapy (Radiotherapy) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Five Days of Mammosite Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method. | 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. | 26 participants completed the 1 year assessment. | Posted | Count of Participants | Participants | one year |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Five Days of Mammosite Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | RTOG Late Scoring | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kira F. Pavlik, CCRP Clinical Research Coordinator Therapeutic Radiology | Yale Comprehensive Cancer Center | (203) 737-2587 | kira.pavlik@yale.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Tumor Stage | Breast cancer tumor size was determined prior to study inclusion. Tis is Carcinoma in situ. T1 tumors are 2 cm or smaller. T1mi is Tumor ≤ 1 0.1cm in greatest dimension. T1a - T1c is ordered smallest to largest (all under 2 cm). | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Lymph node evaluation | Only those with invasive disease were counted. | n = 24 | Count of Participants | Participants |
|
| Size of invasive component | Median | Full Range | centimeters (cm) |
|
| Size of in situ component | Median | Full Range | centimeters (cm) |
|
| Size of in situ component (DCIS patients) | This was only measured in DCIS patients (n=4). | Median | Full Range | centimeters (cm) |
|
| estrogen receptor (ER) | Count of Participants | Participants |
|
| progesterone receptor (PR) | Count of Participants | Participants |
|
| HER2/neu status (invasive disease only) | Only counted in those with invasive disease (n=24). | Count of Participants | Participants |
|
| lymphovascular space invasion (LVSI) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity | These data were not collected and were not summarized in this study. Results are not available. | Posted | Upon completion of study |
|
|
| 0 |
| 28 |
| 13 |
| 28 |
| Fibrosis | Respiratory, thoracic and mediastinal disorders | RTOG Late Scoring | Systematic Assessment |
|
| Telangiectasia | Vascular disorders | RTOG Late Scoring | Systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | RTOG Late Scoring | Systematic Assessment | All skin related issues |
|
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| D017437 |
| Skin and Connective Tissue Diseases |