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Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
NA
Trial ID
NCT04909125
Intervention or treatment
RADIATION: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
Conditions
- • Breast Cancer
- • Post Mastectomy
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
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/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Hypofractionation Arm
| RADIATION: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
|
OTHER: Standard /Conventional fractionation Arm
| RADIATION: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Fatigue | 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 | six weeks post radiation treatment |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Changes in patients' quality of life | Changes 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 outcome | first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years |
| Number of participants with acute radiation dermatitis in irradiated area | Grade 2 or worse radiation dermatitis | During treatment |
| Number of participants with ipsilateral arm lymphoedema | The circumference of the ipsilateral arm \>=10% increased compared to the other arm defines oedema | 3 years post radiation treatment |
| Number of participants with ipsilateral arm range of motion | Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction | 3 years post radiation treatment |
| Disease Recurrence | Any disease progression or recurrence - location and time of event | 5 years from treatment |
| Self reported acute & late radiation toxicities | acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires | first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years |
| Compare the indirect radiation therapy costs by 2 treatment arms | data of cost of attending treatment, work and lifestyle impact are captured by questionnaires | 4 weeks post radiation treatment |
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