NCT04909125

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

Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Breast Cancer
• Post Mastectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-07-31
• Completion: 2027-12-31
• First posted: 2021-06-01
• Last updated: 2026-02-06

Locations

1 site across 1 country: Australia