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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05417516




Registration number
NCT05417516
Ethics application status
Date submitted
7/06/2022
Date registered
14/06/2022
Date last updated
13/01/2025

Titles & IDs
Public title
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Scientific title
A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
Secondary ID [1] 0 0
OCOG-2022-RAPID2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasm Female 0 0
Radiotherapy 0 0
Cosmetic Outcome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Whole Breast Irradiation (WBI)
Treatment: Other - Partial Breast Irradiation (PBI)

Active comparator: Whole Breast Irradiation (WBI) - 26 Gy in 5 fractions to the whole breast

Experimental: Partial Breast Irradiation (PBI) - 26 Gy in 5 fractions to the tumour bed with a margin of normal tissue


Treatment: Other: Whole Breast Irradiation (WBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Treatment: Other: Partial Breast Irradiation (PBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local Recurrence
Timepoint [1] 0 0
Annually for 5 years post-randomization
Primary outcome [2] 0 0
Patient Assessment Cosmesis at 3 years
Timepoint [2] 0 0
3 and 5 years post-randomization
Secondary outcome [1] 0 0
Distant Disease Free Survival (DDSF)
Timepoint [1] 0 0
Annually for 5 years post-randomization.
Secondary outcome [2] 0 0
Disease Free Survival (DFS)
Timepoint [2] 0 0
Annually for 5 years post-randomization.
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
3 years post-randomizaton.
Secondary outcome [4] 0 0
Radiation Toxicity
Timepoint [4] 0 0
2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.
Secondary outcome [5] 0 0
Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
Timepoint [5] 0 0
3 and 5 years post-randomization.
Secondary outcome [6] 0 0
Patient Assessed Cosmesis at 5 years.
Timepoint [6] 0 0
5 years post-randomization.
Secondary outcome [7] 0 0
Patient Reported Quality of Life
Timepoint [7] 0 0
2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.

Eligibility
Key inclusion criteria
For inclusion in this study, patients must fulfill all of the following criteria:

1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease.(AJCC TNM Cancer Staging).
2. Treated by BCS with microscopically clear resection margins = 1mm for invasive and non-invasive disease or no residual disease on re-excision.
3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection.
Minimum age
50 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:

1. Age less than 50 years.
2. Known to be BRCA 1 and/or BRCA 2 positive.
3. Tumour size >3cm in greatest diameter on pathological examination.
4. Lobular carcinoma only.
5. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
6. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
7. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
8. Known pregnancy or currently lactating.
9. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
10. Inability to plan the patient for the experimental technique.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
20/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2031
Actual
Sample size
Target
910
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,Western AustrailiaWA
Recruitment hospital [1] 0 0
GenesisCare Hurstville - Hurstville
Recruitment hospital [2] 0 0
GenesisCare Mater Hospital - North Sydney
Recruitment hospital [3] 0 0
GenesisCare Bundaberg - Bundaberg
Recruitment hospital [4] 0 0
GenesisCare Southport - Southport
Recruitment hospital [5] 0 0
GenesisCare Tugun - Tugun
Recruitment hospital [6] 0 0
GenesisCare St Andrew's - Adelaide
Recruitment hospital [7] 0 0
GenesisCare Fiona Stanley Hospital - Murdoch
Recruitment hospital [8] 0 0
GenesisCare Hollywood - Nedlands
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
4670 - Bundaberg
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
4224 - Tugun
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Ontario Clinical Oncology Group (OCOG)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to determine in women with node negative BC =3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Trial website
https://clinicaltrials.gov/study/NCT05417516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Timothy Whelan, M.D.
Address 0 0
Juravinski Cancer Centre and McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shelley Chambers, MA
Address 0 0
Country 0 0
Phone 0 0
905-527-2299
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/NCT05417516