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Active, not recruiting Not applicable

Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation

NCT04909125 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2021-06-01
Last updated
2026-02-06

Condition(s) studied

Breast CancerPost Mastectomy

Investigational drug(s) / intervention(s)

Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy: The purpose of this study is to investigate toxicity following standard conventional fractionation versus moderately hypofractionated radiotherapy to the breast, chest wall and regional lymph nodes

Study summary

The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years and older * ECOG performance status 0-2 * Ability to understand and willingness to sign a written informed consent document * Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing * Managed with either mastectomy or breast conserving surgery * Suitable for radiation therapy to the breast/chest wall and regional lymph nodes * Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted * Neoadjuvant radiotherapy (reverse sequencing) accepted * Breast implants and expanders are accepted * Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated * Life expectancy minimum 10 years * Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment) Exclusion Criteria: * Prior radiotherapy to the ipsilateral breast or chest wall * Pregnancy or lactation * Radiosensitivity syndrome * Permanent pacemaker/defibrillator within radiotherapy field * Oncoplastic surgery where boost volume unacceptable (clinician discretion) * Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)

Primary outcome measure(s)

  • Fatigue — six weeks post radiation treatment
    Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome

Trial sites (1)

FacilityCityRegionStatus
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital St Leonards New South Wales
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04909125 on ClinicalTrials.gov ↗ ← All trials in Australia