Breast CancerNCT04909125
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
A study testing Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy in people with Breast Cancer and Post Mastectomy, run by Royal North Shore Hospital at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Post Mastectomy
- What is being tested?
- Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
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
Read the 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
- Being tested
- Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
- Keywords
- radiotherapy, hypofractionation, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation Arm | Active comparator | 40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight) Receives: Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy |
| Standard /Conventional fractionation Arm | Other | 50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight) Receives: Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
Measured: six weeks post radiation treatment
Secondary outcomes (7)
Changes in patients' quality of life
Changes in patients' quality of life during radiotherapy and follow up period are captured by questionnaires. The questions are for examples how difficult is it in planning or being able to continue your usual activities?, how often have you felt low in energy? The score scales are from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
Measured: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Number of participants with acute radiation dermatitis in irradiated area
Grade 2 or worse radiation dermatitis
Measured: During treatment
Number of participants with ipsilateral arm lymphoedema
The circumference of the ipsilateral arm >=10% increased compared to the other arm defines oedema
Measured: 3 years post radiation treatment
Number of participants with ipsilateral arm range of motion
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
Measured: 3 years post radiation treatment
Disease Recurrence
Any disease progression or recurrence - location and time of event
Measured: 5 years from treatment
Self reported acute & late radiation toxicities
acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires
Measured: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Compare the indirect radiation therapy costs by 2 treatment arms
data of cost of attending treatment, work and lifestyle impact are captured by questionnaires
Measured: 4 weeks post radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Jul 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Responsible party
- Sponsor
- Investigators
- Susan Carroll, MBBS FRANZCR, Principal investigator, Radiation Oncology Department, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909125
- Sponsor's protocol ID
- SVIFT Nodal Trial
- Status last verified
- Feb 2026
- First submitted
- 26 May 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
- ClinicalTrials.gov ID
- NCT04909125
- Acronym / sponsor ID
- SVIFT Nodal Trial
- Conditions
- Breast Cancer, Post Mastectomy
- Keywords
- radiotherapy, hypofractionation, quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation Arm | Active comparator | Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight) |
| Standard /Conventional fractionation Arm | Other | Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapyThe 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 | Radiation | Hypofractionation Arm, Standard /Conventional fractionation Arm |
Primary outcome
Fatigue
Time frame: six weeks post radiation treatment
Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
7 secondary outcomes
Changes in patients' quality of life
Time frame: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Number of participants with acute radiation dermatitis in irradiated area
Time frame: During treatment
Number of participants with ipsilateral arm lymphoedema
Time frame: 3 years post radiation treatment
Number of participants with ipsilateral arm range of motion
Time frame: 3 years post radiation treatment
Disease Recurrence
Time frame: 5 years from treatment
Self reported acute & late radiation toxicities
Time frame: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Compare the indirect radiation therapy costs by 2 treatment arms
Time frame: 4 weeks post radiation treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Carroll, MBBS FRANZCR principal investigator
Radiation Oncology Department, Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy in people with Breast Cancer and Post Mastectomy, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: six weeks post radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.