Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
21/11/2023

Titles & IDs
Public title
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
Scientific title
Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
Secondary ID [1] 0 0
SVIFT Nodal Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Post Mastectomy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fatigue
Timepoint [1] 0 0
six weeks post radiation treatment
Secondary outcome [1] 0 0
Changes in patients' quality of life
Timepoint [1] 0 0
first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Secondary outcome [2] 0 0
Number of participants with acute radiation dermatitis in irradiated area
Timepoint [2] 0 0
During treatment
Secondary outcome [3] 0 0
Number of participants with ipsilateral arm lymphoedema
Timepoint [3] 0 0
3 years post radiation treatment
Secondary outcome [4] 0 0
Number of participants with ipsilateral arm range of motion
Timepoint [4] 0 0
3 years post radiation treatment
Secondary outcome [5] 0 0
Disease Recurrence
Timepoint [5] 0 0
5 years from treatment
Secondary outcome [6] 0 0
Self reported acute & late radiation toxicities
Timepoint [6] 0 0
first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Secondary outcome [7] 0 0
Compare the indirect radiation therapy costs by 2 treatment arms
Timepoint [7] 0 0
4 weeks post radiation treatment

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT04909125
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan Carroll, MBBS FRANZCR
Address 0 0
Radiation Oncology Department, Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Heidi Tsang
Address 0 0
Country 0 0
Phone 0 0
(02)94631346
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04909125