Breast Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONAdjuvant Ultra hypofractionation radiotherapy
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
RADIATIONAdjuvant Hypofarctionated radiotherapy
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
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Histological diagnosis of breast adenocarcinoma * Prior breast conservative surgery negative resection margins (3 mm) * Pathological stage pT1-pT2, N0-1, pT3-N0, M0 * No macroscopic evidence of distant metastases at diagnosis * Age 18-80 years * Female patients * Normal hematological and biochemical laboratory tests * Written informed consent was obtained from all patients
Exclusion criteria
• Patients underwent mastectomy. * Locally advanced disease pT4, N2,3. * Positive surgical margins * Prior thoracic radiation * Synchronous second primary tumor * Distant metastases * Pregnancy * Presence of a concomitant psychiatric disorder precluding an aware informed consent. * Age \>80 years * Low risk patient meeting all the following criteria (more than or equal 65 years, PT1, grade 1 or 2, +ER, -Her2nu, N0, M0).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Skin Toxicity (CTCAE v5.0) | From start of radiotherapy to 6 weeks post-treatment | Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Skin Toxicity and Cosmesis | 12 months post-radiotherapy | 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) |
| Locoregional Recurrence | Up to 24 months post-radiotherapy | Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits |
Countries
Egypt
Outcome results
None listed