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| Name | Class |
|---|---|
| Northern Sydney and Central Coast Area Health Service | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation Arm | Active Comparator | 40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight) |
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| Standard /Conventional fractionation Arm | Other | 50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy | Radiation | 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Carroll, MBBS FRANZCR | Radiation Oncology Department, Royal North Shore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Patients will be randomised to one of the arms and will be notified for the randomization results. Randomisation ratio 2:1 (hypofractionation : standard)
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |