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| ID | Type | Description | Link |
|---|---|---|---|
| 113-S0087 | Other Grant/Funding Number | National Taiwan University Hospital Yunlin Branch |
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Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBB | Hypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral breast tumor recurrence | The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months) | From enrollment to the end of treatment at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Early Phase Acute Skin Toxicity | Acute skin toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5) | Up to 3 months following completion of radiotherapy |
| Late Phase Breast Fibrosis |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yen-Ting Liu | Contact | 88697255451 | nickliucool@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Not yet recruiting | Taipei | Taiwan | 100 | Taiwan |
Anonymized patient-level clinical data necessary to replicate the main study findings
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Late breast fibrosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5) |
| From 3 months up to 5 years following completion of radiotherapy |
| Patient Quality of Life (EORTC QLQ-C30) | Quality of life evaluation using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100) | At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years) |
| Patient Quality of Life (EORTC QLQ-BR23) | Quality of life evaluation using the Breast Cancer Module (BR23) of the European Organization for Research and Treatment of Cancer, Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100) | At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years) |
| National Taiwan University Hospital Yunlin Branch | Recruiting | Taipei | 632 | Taiwan |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |