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| Name | Class |
|---|---|
| Kasr El Aini Hospital | OTHER |
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The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation | Experimental | Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly hypofractionation for early breast cancer | Radiation | Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cosmetic breast appearance | according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor | six months |
| Acute radiation toxicity assessment | according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse. | six months |
| Patient quality of life assessment. | according to FACT-B | six months |
| Patient satisfaction. | according to FACIT-TS-PS | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mona M Salem, MSc | Contact | 00201007731412 | mona.m.salem@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mona Salem, MSc | Kasr El AiniH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El AiniH | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |