Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000659808
Ethics application status
Approved
Date submitted
25/11/2020
Date registered
31/05/2021
Date last updated
31/05/2021
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic Resonance Image Guided Single Fraction Preoperative Radiotherapy for Early Breast Cancer
Scientific title
Feasibility of Magnetic Resonance Image Guided Single Fraction Preoperative Radiotherapy for Early Breast Cancer
Secondary ID [1] 302862 0
Nil known
Universal Trial Number (UTN)
U1111-1261-7219
Trial acronym
RICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 319858 0
Condition category
Condition code
Cancer 317792 317792 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention: Magnetic resonance image guided single fraction (21Gy) neo-adjuvant breast radiotherapy administered over a period of 5-10 minutes approximately 6 weeks prior to surgery. Fraction will be delivered to a single lesion by a multidiciplinary team including Radiation Oncologist, radiation therapist, medical physicist and MR radiographers. The fraction delivered will be recorded in the patients medical record and will be reviewed by the clinical team prior to surgery.
Intervention code [1] 319150 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325815 0
To determine the feasibility of MRI guided single fraction neo-adjuvant breast radiotherapy. Feasibility will be defined as the ability to plan and deliver a pre-operative single fraction of SABR within 48 hours. This will be collected from data linkage with hospital electronic medical records.
Timepoint [1] 325815 0
Monitored from trial entry to delivery of intervention
Secondary outcome [1] 389228 0
Pathological response in resected tumour tissue following the delivery of intervention and in 12 months follow up as assessed by PET/MRI imaging.
Timepoint [1] 389228 0
At time of surgery and time of disease progression or 12 months post treatment, which ever occurs first.
Secondary outcome [2] 391023 0
Quantitative comparison between planning volumes and dosimetry for planning-MR image guidance vs. CT for planning-CBCT image guidance.
Timepoint [2] 391023 0
Enrollment on study until delivery of intervention
Secondary outcome [3] 396264 0
Quantification of dosimetric differences comparing CT and Cone Beam CT.
Timepoint [3] 396264 0
Radiation therapy planning period which occurs pre-dose administration.
Secondary outcome [4] 396285 0
To evaluate the impact of MRI guided single fraction neo-adjuvant breast radiotherapy on quality of life as measured by EORTC QLQ-C30 and QLQ-BR23.
Timepoint [4] 396285 0
Report measurements will occur at study enrolment, on day of radiotherapy treatment after treatment, two weeks post-surgery and at 12 month follow up.
Secondary outcome [5] 396286 0
Exploratory outcome measure: quantification of changes in blood biomarkers before and after intervention.
Timepoint [5] 396286 0
Study enrolment, on day of radiotherapy treatment after treatment, two weeks post-surgery and at 12 months follow up.

Eligibility
Key inclusion criteria
1. Age 60 years or older
2. Unifocal Breast Cancer
3. Tumour Size on pre-treatment imaging equal to or greater than 2 cm
4. Grade <3 on pre-treatment core biopsy
5. Oestrogen receptor (ER) and Progesterone (PR) positive (>10%)
6. Clinically node negative
7. Willing and able to provide informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous RT to same breast
2. Suspicious diffuse microcalcifications
3. Invasive lobular carcinoma on core biopsy
4. Lymphovascular invasion on core biopsy
5. Any clinical nodal or metastatic disease
6. HER2 positive
7. Prior non-hormonal therapy
8. Skin or chest wall involvement
9. Collagen vascular disease, e.g. lupus, scleroderma
10. Pregnant or lactating
11. Contraindications to MRI e.g. pacemaker, severe claustrophobia
12. Unable or unwilling to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive summary statistics will be prepared to report the proportion of patients who can be feasibly treated with the MRI guided single fraction techniques using adapt to position and shape.
Secondary measures that will be collected as categorical values (i.e. Clavien grade) will be presented as counts and percentage frequency, while continuous variables (i.e. Quality of Life or Patient Reported Outcome Measures) will be presented as mean ± standard deviation if normally distributed or median (Inter-quartile range) if skewed. Appropriate parametric or non-parametric tests will be applied if comparisons between groups are possible. Rate of recurrence will be considered via time to event analysis using the Kaplan-Meier method and cox regression analysis if the sample size allows.
Statistical analysis will be conducted using Stata v15.1 (StataCorp, College Station, Texas, USA) with a p-value of less than 0.05 considered to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/06/2021
Actual
Date of last participant enrolment
Anticipated
3/01/2022
Actual
Date of last data collection
Anticipated
3/01/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18085 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 32074 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 307280 0
Government body
Name [1] 307280 0
National Breast Cancer Foundation
Country [1] 307280 0
Australia
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Level 5, Olivia Newton-John Cancer Wellness and Research Centre, 145 Studley Rd, Heidelberg, 3084, VICTORIA
Country
Australia
Secondary sponsor category [1] 307917 0
None
Name [1] 307917 0
Address [1] 307917 0
Country [1] 307917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307378 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307378 0
145 Studley Rd, Heidelberg, VIC 3084
Ethics committee country [1] 307378 0
Australia
Date submitted for ethics approval [1] 307378 0
29/04/2020
Approval date [1] 307378 0
04/09/2020
Ethics approval number [1] 307378 0
HREC/61503/Austin-2020

Summary
Brief summary
This trial is investigating the feasibility of pre-operative high-dose radiation in early breast cancer patients.

Who is it for?
You may be eligible for this trial if you are a female aged 60 or over, with unifocal breast cancer graded <3 on core biopsies. You must also be oestrogen and progesterone receptor positive, and clinically node negative.

Study details
Parents recruited to this study will be offered a high radiation dose delivered in a single treatment using an MRI-guided linear accelerator, 6 weeks prior to surgery. They will be followed up for disease response and progression.

It is hoped that this study will help investigators examine the feasibility of pre-operative single dose radiotherapy, which may reduce patient inconvenience as well as potentially decreasing side effects of extended radiation treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107018 0
A/Prof Farshad Foroudi
Address 107018 0
Radiation Oncology
Austin Health
L1, Olivia Newton-John Cancer Wellness and Research Centre, 145 Studley Rd, Heidelberg VIC 3084
Country 107018 0
Australia
Phone 107018 0
+61 03 9496 9419
Fax 107018 0
Email 107018 0
farshad.foroudi@austin.org.au
Contact person for public queries
Name 107019 0
Dr Jodie Palmer
Address 107019 0
Olivia Newton-John Cancer Research Institute
L5 ONJCRWC, 145 Studley Rd, Heidelberg, VIC 3084
Country 107019 0
Australia
Phone 107019 0
+61 03 9496 5000
Fax 107019 0
Email 107019 0
trials@onjcri.org.au
Contact person for scientific queries
Name 107020 0
A/Prof Farshad Foroudi
Address 107020 0
Radiation Oncology
Austin Health
L1, Olivia Newton-John Cancer Wellness and Research Centre, 145 Studley Rd, Heidelberg VIC 3084
Country 107020 0
Australia
Phone 107020 0
+61 03 9496 9419
Fax 107020 0
Email 107020 0
farshad.foroudi@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only cohort data will be published once collected.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.