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Ultrahypofractionated Versus Normofractionated Sequential Boost After Whole-breast Radiation Therapy in Patients Treated With Breast-conserving Surgery for Breast Cancer

NCT07590505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-15

No results posted yet for this study

Summary

The ULTIMO trial is a monocentric, prospective, randomised controlled, open-label, phase III interventional clinical trial, with a non-inferiority design, in patients with breast cancer undergoing breast conservative treatment (BCT). After giving informed consent and verifying eligibility, data collection starts and patients will be randomized in one of the following treatment arms:

* Standard treatment arm: Breast Conserving Surgery (BCS) takes place, followed by the SoC hypofractionated Whole Breast Radiation Therapy (WBRT) and SoC normofractioned sequential boost (normSEB) of 10Gy over 5 fractions.
* Experimental treatment arm: Breast Conserving Surgery (BCS) takes place, followed by the SoC hypofractionated WBRT and experimental ultrahypofractionated sequential boost (ultSEB) of 6Gy in a single fraction.

The primary objective of the ULTIMO study is to assess whether the ultSEB RT boost protocol is non-inferior to the current SoC normSEB RT boost protocol. This assessment will be based on the cosmetic outcome of the breasts, while also taking into account quality of life (QoL), the frequency and intensity of (S)AEs of interest (breast pain and fibrosis), and oncological survival.

Conditions

Interventions

RADIATION

Standard of Care (SOC) - Normofractionated Sequential Boost Radiation Therapy

Standard of care fractionation and dosage scheme of the sequential radiation therapy boost. This consists of 5 fractions of 2Gy each, adding up to a total dose of 10Gy.

RADIATION

Experimental - UltraHypofractionated Sequential Boost Radiation Therapy

The radiation therapy sequential boost is delivered in a ultrahypofractionated scheme. This consists of a single fraction of 6Gy.

Sponsors & Collaborators

  • Ziekenhuis aan de Stroom

    collaborator OTHER

  • Gasthuis Zusters Antwerpen

    collaborator OTHER

  • Iridium netwerk

    collaborator UNKNOWN

  • Cancer Research Antwerp

    lead OTHER

Principal Investigators

  • Melanie Machiels, MD, PhD · Iridium netwerk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2025-11-28
Completion
2026-03-25

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT07590505 on ClinicalTrials.gov