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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

NCT06909032 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-04-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Icon Cancer Foundation (ICF)

    collaborator UNKNOWN

  • Integrated Community Oncology Network

    lead OTHER

Principal Investigators

  • John Boyages, MB BS(Hons), FRANZCR, PhD, AM · Integrated Community Oncology Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2030-07-31
Completion
2032-12-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909032 on ClinicalTrials.gov