- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04909125
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heidi Tsang
- Phone Number: (02)94631346
- Email: heidi.tsang@health.nsw.gov.au
Study Contact Backup
- Name: Shintelle Newbond
- Phone Number: (02)94631345
- Email: shintelle.newbond@health.nsw.gov.au
Study Locations
-
-
New South Wales
-
St Leonards, New South Wales, Australia, 2065
- Recruiting
- Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
-
Contact:
- Heidi Tsang
- Phone Number: 94631340
- Email: heidi.tsang@health.nsw.gov.au
-
Contact:
- Shintelle Newbond
- Phone Number: 94631345
- Email: shintelle.newbond@health.nsw.gov.au
-
Principal Investigator:
- Susan Carroll
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hypofractionation Arm
40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)
|
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
|
Other: Standard /Conventional fractionation Arm
50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
six weeks post radiation treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in patients' quality of life
Time Frame: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
|
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
|
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
|
Grade 2 or worse radiation dermatitis
|
During treatment
|
Number of participants with ipsilateral arm lymphoedema
Time Frame: 3 years post radiation treatment
|
The circumference of the ipsilateral arm >=10% increased compared to the other arm defines oedema
|
3 years post radiation treatment
|
Number of participants with ipsilateral arm range of motion
Time Frame: 3 years post radiation treatment
|
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction
|
3 years post radiation treatment
|
Disease Recurrence
Time Frame: 5 years from treatment
|
Any disease progression or recurrence - location and time of event
|
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
|
acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires
|
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
|
data of cost of attending treatment, work and lifestyle impact are captured by questionnaires
|
4 weeks post radiation treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Carroll, MBBS FRANZCR, Radiation Oncology Department, Royal North Shore Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SVIFT Nodal Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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