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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-0268 | Other Identifier | Institutional Review Board |
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lost funding
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Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | breast brachytherapy to a dose of 34 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation | breast brachytherapy to 34 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years | 3 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Patel, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20732760 | Background | McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Brachytherapy to 34 Gy | breast brachytherapy to a dose of 34 Gy brachytherapy: breast brachytherapy to 34 Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Brachytherapy to 34 Gy | breast brachytherapy to a dose of 34 Gy brachytherapy: breast brachytherapy to 34 Gy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT | No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available. | Posted | 5 years |
|
|
The study was terminated early, adverse events data were collected on paper that presumably are with the PI.
No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.
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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 | Breast Brachytherapy to 34 Gy | breast brachytherapy to a dose of 34 Gy brachytherapy: breast brachytherapy to 34 Gy |
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We were able to find a published paper that may represent some of the results of this study (linked in the references section of the protocol). The number of participants does not match our records as our records for this study are incomplete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Trask, research coordinator for study | UW Hospital and Clinics | 608-263-9528 | trask@humonc.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2006 | Oct 1, 2018 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years | No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available. | Posted | 3 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |