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
NCT ID: NCT06909032
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
168 participants
INTERVENTIONAL
2025-04-30
2032-12-31
Brief Summary
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Detailed Description
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Follow-up will be at the following time points:
* Eight weeks following the end of radiation
* Every six months post-randomisation for two years following randomisation
* Three years post-randomisation (final visit)
Assessments to be conducted at each time point are:
* Clinical assessment
* Completion of Patient-Reported Outcome Measures (PROMs)
* Mammogram and ultrasound (baseline and annually)
* Documentation of IBTR - classified as a true recurrence or Elsewhere
* Documentation of any other type of recurrence (regional, distant, opposite breast)
Recruitment is planned for three years with a three-year follow-up period for all patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A: Hypofractionated PBI delivering a total dose of 30 Gy in five consecutive daily fractions.
PBI will be delivered using a VMAT planning and delivery technique. Prior to treatment patients are required to attend a treatment planning session that will assist with planning the treatment. The planning procedure will take up to approximately 60 minutes and involve a computed-tomography (CT) scan with the patient positioned in the treatment position. Treatment is expected to take around 15 minutes per treatment. The intervention will be prescribed by a radiation oncologist and administered by radiation therapists. During treatment, imaging will be completed to ensure treatment is administered accurately.
All patients will complete breast cancer related quality of life questionnaires.
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.
Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions.
The comparator for this study is another dose that is used as standard of care for APBI in Australia and globally.
Planning and treatment procedures will be same as that for Arm A.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Infiltrating ductal carcinoma (IDC) or pure DCIS, less than or equal to 20mm maximum size.
* Lobular carcinoma in situ (LCIS) is permitted.
* Histologic grade I or II
* Estrogen receptor (ER) +/- progesterone receptor (PR) positive in greater than or equal to 10% of cells and HER2 receptor-negative.
* Tumour bed identifiable on imaging via surgical clips
* Clear surgical margins
* Sentinel nodes negative (at least one node taken if invasive and no isolated tumour cells)
* No evidence of distant metastasis
Exclusion Criteria
* Lymphatic vessel invasion (LVI)
* Bilateral breast cancer
* Invasive lobular carcinoma
* Pleomorphic LCIS
* Multifocal or multicentric invasive cancer
* Invasive carcinoma with associated DCIS greater than or equal to 30mm.
* Patients receiving neoadjuvant chemotherapy, anti-HER2 agents or endocrine therapy
* Patients receiving adjuvant chemotherapy or anti-HER2 agents.
* Previous Hodgkin's lymphoma requiring mantle radiation
* Prior radiation therapy to the ipsilateral breast
* Triple-negative breast cancer
* Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer
* Known inflammatory conditions associated with higher complications after RT, such as active scleroderma, systemic lupus erythematosus (requiring steroids or immune suppressive therapy)
* Oncoplastic surgery where the primary tumour site is difficult to delineate
* No previous cancer (except BCC or SCC of the skin) unless in remission beyond five years of diagnosis
* People who are pregnant or planning to become pregnant
* People who are unable or unwilling to comply with protocol requirements.
50 Years
FEMALE
No
Sponsors
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Icon Cancer Foundation (ICF)
UNKNOWN
Integrated Community Oncology Network
OTHER
Responsible Party
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Principal Investigators
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John Boyages, MB BS(Hons), FRANZCR, PhD, AM
Role: STUDY_CHAIR
Integrated Community Oncology Network
Locations
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Icon Cancer Centre Wahroonga
Wahroonga, New South Wales, Australia
Icon Cancer Centre Windsor Gardens
Windsor Gardens, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23.05
Identifier Type: -
Identifier Source: org_study_id
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