Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer (UHF vs HF-EBC)

Zagazig University

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Adjuvant Hypofarctionated radiotherapy; Radiation: Adjuvant Ultra hypofractionation radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07274800

11119 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Adjuvant Ultra hypofractionation radiotherapy

Arm B: Adjuvant hypofractionation radiotherapy

Experimental group

Treatment:

Radiation: Adjuvant Hypofarctionated radiotherapy