Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer

Zagazig University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Adjuvant Ultra hypofractionation radiotherapyRADIATION

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

Adjuvant Hypofarctionated radiotherapyRADIATION

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (1)

Zagazig University

Zagazig, Egypt

Outcomes

Primary Outcomes

Acute Skin Toxicity (CTCAE v5.0)

Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed

Time frame: From start of radiotherapy to 6 weeks post-treatment

Secondary Outcomes

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)

Time frame: 12 months post-radiotherapy

Locoregional Recurrence

Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits

Time frame: Up to 24 months post-radiotherapy

Data from ClinicalTrials.gov

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