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Clinical Trials/NCT07274800
NCT07274800
Completed
Not Applicable

Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer

Zagazig University1 site in 1 country60 target enrollmentStarted: November 27, 2023Last updated:
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Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Acute Skin Toxicity (CTCAE v5.0)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts 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,
  • •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).

Outcomes

Primary Outcomes

Acute Skin Toxicity (CTCAE v5.0)

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

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

Secondary Outcomes

  • Late Skin Toxicity and Cosmesis(12 months post-radiotherapy)
  • Locoregional Recurrence(Up to 24 months post-radiotherapy)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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