Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer

NCT ID: NCT07274800

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2025-11-27

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A:Adjuvat 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

Group Type: EXPERIMENTAL

Adjuvant Ultra hypofractionation radiotherapy

Intervention Type: 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

Arm B: Adjuvant hypofractionation radiotherapy

Group Type: EXPERIMENTAL

Adjuvant Hypofarctionated radiotherapy

Intervention Type: 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

Interventions

Adjuvant 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

Intervention Type: RADIATION

Adjuvant 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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zagazig University

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

11119

Identifier Type: -

Identifier Source: org_study_id