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breast-conserving surgery. One group receives ultra-hypofractionated radiotherapy (26 Gy in 5 sessions over 1 week), while the other group receives hypofractionated radiotherapy (40 Gy in 15 sessions over 3 weeks). The study aims to compare skin toxicity, cosmetic outcomes, and local cancer control between thetwo schedules . Participants are followed during and after radiotherapy for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy | Experimental | Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation |
|
| Arm B: Adjuvant hypofractionation radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Ultra hypofractionation radiotherapy | Radiation | Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Skin Toxicity (CTCAE v5.0) | Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed | From start of radiotherapy to 6 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Late Skin Toxicity and Cosmesis | Incidence of late skin changes (pigmentation, fibrosis) and cosmetic outcomes assessed at 12 months post-radiotherapy using physician assessment and patient-reported outcomes (EORTC QLQ) | 12 months post-radiotherapy |
| Locoregional Recurrence |
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Inclusion Criteria:• Histological diagnosis of breast adenocarcinoma
Exclusion Criteria: • Patients underwent mastectomy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Zagazig | Egypt |
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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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|
| Adjuvant Hypofarctionated radiotherapy | Radiation | Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 40 Gy delivered in 15 fractions over 3 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation |
|
Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits |
| Up to 24 months post-radiotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |