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NOT YET RECRUITING
NCT06909032
NA

Accelerated Partial Breast Irradiation Using External Beam Volumetric Modulated Arc Therapy (VMAT): a Randomised Non-inferiority Trial of 30 Gy Versus 26 Gy in Five Fractions Investigating Patient-reported Outcomes

Sponsor: Integrated Community Oncology Network

View on ClinicalTrials.gov

Summary

For women undergoing radiotherapy following surgery for early-stage breast cancer, breast-related quality of life (BrQoL) is an important consideration. Treating only the part of the breast by radiation where the cancer has been surgically removed (partial breast irradiation or "PBI") rather than the whole breast (whole breast irradiation) can reduce the toxic effects of radiotherapy. This trial aims to evaluate whether there is a difference in patient-reported BrQoL between two total doses of radiation given in five treatments using PBI. If BrQOL for the higher dose of PBI is no worse than the lower dose, using the higher dose would be advised as best practice, given that it is more likely to be more effective in reducing the chance of cancer coming back in the breast than the lower dose.

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-04

Completion Date

2032-12

Last Updated

2025-04-03

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Accelerated partial breast irradiation

Accelerated partial breast irradiation (APBI) will be delivered using Volumetric Modulated Arc Therapy (VMAT). Treatment will be started within 12 weeks of breast conserving surgery and within four weeks of randomisation. Treatment will occur in five (5) once-daily sessions and should be completed within seven (7) days of starting radiotherapy. Two total doses of APBI will be compared: 30 Gy and 26 Gy. The aim is to determine whether quality of life is no worse when a higher dose of APBI is used compared to a slightly lower dose of APBI. The results of this study will help to guide doctors choose the best dose of APBI for patients with early breast cancer in the future.

Locations (2)

Icon Cancer Centre Wahroonga

Wahroonga, New South Wales, Australia

Icon Cancer Centre Windsor Gardens

Windsor Gardens, South Australia, Australia