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

Sponsor
Cancer Research Antwerp
Study ID
NCT07590505
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care (SOC) - Normofractionated Sequential Boost Radiation Therapy — RADIATION
    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.
  • Experimental - UltraHypofractionated Sequential Boost Radiation Therapy — RADIATION
    The radiation therapy sequential boost is delivered in a ultrahypofractionated scheme. This consists of a single fraction of 6Gy.

Study Details

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.

Key Dates

Start date
Mar 29, 2022
Status verified
May 2026
Primary completion
Nov 28, 2025
Completion
Mar 25, 2026

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard treatment arm (SoC; Normofractionated boost RT)
    In the control arm, the boost of the radiation therapy will be delivered according to the standard of care fractionation and dosage scheme. This consists of 5 fractions of 2Gy each, adding up to a total dose of 10Gy. All other treatments are not considered to be study-specific and are performed according to the standard of care treatment for breast cancer.
  • Experimental: Experimental treatment arm (Hypofractionated boost RT)
    In the experimental arm, the boost of the radiation therapy is delivered in a ultrahypofractionated scheme. This consists of a single fraction of 6Gy. All other treatments are not considered to be study-specific and are performed according to the standard of care treatment for breast cancer.

Primary Outcome Measure

Cosmetic non-inferiority - BCCT.core scoring [ Time Frame: From enrollment to the end of follow-up at 3 years of follow-up, counting from the last study visit. ]

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