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Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy

NCT06007118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-08-23

No results posted yet for this study

Summary

The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.

Conditions

Interventions

RADIATION

APBI

accelerated partial breast irradiation to the surgery bed (5 x 6,0 Gy; in 5 working days)

RADIATION

WBI

accelerated whole breast irradiation with the boost to tumor bed (15x 2,67 Gy + 5x 2,0 Gy, every working day)

Sponsors & Collaborators

  • Masaryk Memorial Cancer Institute

    lead OTHER

Principal Investigators

  • Petr Burkon, M.D., Ph.D. · Masaryk Memorial Cancer Institute, Dept. of Radiation Oncology,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2023-07-07
Completion
2023-07-07

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007118 on ClinicalTrials.gov