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

RECRUITING

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.

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Study details:

Breast cancer is the most commonly diagnosed cancer in Australia. Radiotherapy to the breast, chest wall and regional lymph nodes for breast cancer after surgery can reduce the risk of local recurrence by 50% and reduce breast cancer mortality. Traditionally, radiotherapy is delivered in a large number of small doses i.

e. 25 treatment sessions over 5 1/2 weeks. Another approach is to give a lower number of larger doses i.

e. 15 sessions over 3 1/2 weeks (hypofractionated radiotherapy). Several studies in Europe and Asia have investigated hypofractionated radiotherapy to the chest wall, breast and regional lymph nodes following surgery for breast cancer, and found that it is equally effective to standard treatment, with similar side effects.

These two approaches have not been directly compared in Australia. This trial is to compare these two approaches, to determine whether hypofractionated radiotherapy is better tolerated by patients.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2021-06-01

    Primary completion: 2026-12-31

    Study completion finish: 2027-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04909125

    Intervention or treatment

    RADIATION: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

    Conditions

    • Breast Cancer
    • Post Mastectomy
    Image related to Breast Cancer
    • Condition: Breast Cancer, Post Mastectomy

    • RADIATION: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

    • St Leonards, New South Wales, Australia

    • Sponsor: Royal North Shore Hospital

    Find a site

    Closest Location:

    Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital

    Research sites nearby

    Select from list below to view details:

    • Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital

      St Leonards, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Hypofractionation Arm
    • 40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)
    RADIATION: 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
    OTHER: Standard /Conventional fractionation Arm
    • 50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)
    RADIATION: 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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    FatigueChanges 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 outcomesix weeks post radiation treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Changes in patients' quality of lifeChanges in patients' quality of life during radiotherapy and follow up period are captured by questionnaires. The questions are for examples how difficult is it in planning or being able to continue your usual activities?, how often have you felt low in energy? The score scales are 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 outcomefirst to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
    Number of participants with acute radiation dermatitis in irradiated areaGrade 2 or worse radiation dermatitisDuring treatment
    Number of participants with ipsilateral arm lymphoedemaThe circumference of the ipsilateral arm \>=10% increased compared to the other arm defines oedema3 years post radiation treatment
    Number of participants with ipsilateral arm range of motionImpaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction3 years post radiation treatment
    Disease RecurrenceAny disease progression or recurrence - location and time of event5 years from treatment
    Self reported acute & late radiation toxicitiesacute radiation toxicities during treatment and late radiation toxicities are captured by questionnairesfirst to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
    Compare the indirect radiation therapy costs by 2 treatment armsdata of cost of attending treatment, work and lifestyle impact are captured by questionnaires4 weeks post radiation treatment

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation

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