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| ID | Type | Description | Link |
|---|---|---|---|
| KMünsterlingen | Other Identifier | KMünsterlingen |
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In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast cancer | observation of intraoperative radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| number of Participants with local recurrence histologically proven | Recurrence of breast cancer proven by histology | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| observation of acute and late effects of Radiotherapy | acute effects of Radiotherapy are assessed by Common Toxicity Criteria for Adverse Effects (CTCAE Version 4.0) and late effects of Radiotherapy are assessed by Late Effects Normal Tissue Subjective Objective Management Analysis (LENT-SOMA) | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| observation of influence of smoking | Patients are asked how many cigarettes they smoke. | up to 10 years |
Inclusion Criteria:
Exclusion Criteria:
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women with breast cancer breast-conserving therapy
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Reuter, Dr. med. | Kantonsspital Münsterlingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KMünsterlingen | Münsterlingen | Thurgau | 8596 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17577015 | Background | Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Overall survival |
The number of Patients who died is assessed. |
| up to 10 years |
| Quality of life | Quality of life is assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) cancer modul (C30) EORTC-QLQ-C30 version 3.0 and breast cancer modul (BR23) EORTC-QLQ-BR23 | up to 10 years |
| Cosmesis | Cosmesis is assessed by Photographs and evaluated automatically. | up to 10 years |