Status:
ACTIVE_NOT_RECRUITING
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
Lead Sponsor:
Royal North Shore Hospital
Conditions:
Breast Cancer
Post Mastectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 regiona...
Detailed Description
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 recurrenc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04909125
Start Date
June 1 2021
End Date
December 31 2027
Last Update
April 8 2025
Active Locations (1)
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1
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065