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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04909125
Registration number
NCT04909125
Ethics application status
Date submitted
26/05/2021
Date registered
1/06/2021
Titles & IDs
Public title
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
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Scientific title
Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
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Secondary ID [1]
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SVIFT Nodal Trial
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Post Mastectomy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
Active comparator: Hypofractionation Arm - 40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)
Other: Standard /Conventional fractionation Arm - 50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)
Treatment: Other: 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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Fatigue
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Assessment method [1]
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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
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Timepoint [1]
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six weeks post radiation treatment
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Secondary outcome [1]
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Changes in patients' quality of life
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Assessment method [1]
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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
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Timepoint [1]
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first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
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Secondary outcome [2]
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Number of participants with acute radiation dermatitis in irradiated area
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Assessment method [2]
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Grade 2 or worse radiation dermatitis
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Timepoint [2]
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During treatment
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Secondary outcome [3]
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Number of participants with ipsilateral arm lymphoedema
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Assessment method [3]
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The circumference of the ipsilateral arm \>=10% increased compared to the other arm defines oedema
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Timepoint [3]
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3 years post radiation treatment
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Secondary outcome [4]
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Number of participants with ipsilateral arm range of motion
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Assessment method [4]
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Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction
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Timepoint [4]
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3 years post radiation treatment
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Secondary outcome [5]
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Disease Recurrence
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Assessment method [5]
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Any disease progression or recurrence - location and time of event
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Timepoint [5]
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5 years from treatment
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Secondary outcome [6]
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Self reported acute & late radiation toxicities
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Assessment method [6]
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acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires
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Timepoint [6]
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first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
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Secondary outcome [7]
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Compare the indirect radiation therapy costs by 2 treatment arms
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Assessment method [7]
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data of cost of attending treatment, work and lifestyle impact are captured by questionnaires
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Timepoint [7]
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4 weeks post radiation treatment
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Eligibility
Key inclusion criteria
* 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
* 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
132
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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
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Trial website
https://clinicaltrials.gov/study/NCT04909125
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Susan Carroll, MBBS FRANZCR
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Address
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Radiation Oncology Department, Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Heidi Tsang
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Address
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Country
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Phone
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(02)94631346
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04909125