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Clinical Trials in Canada / NCT05417516
Recruiting Phase 3

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

NCT05417516 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2023-11-20
Last updated
2026-09-14

Condition(s) studied

Breast Neoplasm FemaleRadiotherapyCosmetic Outcome

Investigational drug(s) / intervention(s)

Whole Breast Irradiation (WBI)Partial Breast Irradiation (PBI)

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).

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).

Study 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.

Eligibility

Sex
FEMALE
Min age
50 Years
Max age
120 Years
Healthy volunteers
No
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 (see AJCC TNM Cancer Staging, Appendix II). 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 or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy 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. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible 5. Evidence of a DCIS component \> 3cm 6. Lobular carcinoma only. 7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible). 8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible). 9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma. 10. Known pregnancy or currently lactating. 11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma). 12. Inability to plan the patient for the experimental technique.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
GenesisCare Darlinghurst Darlinghurst New South Wales Recruiting
GenesisCare Hurstville Hurstville New South Wales Recruiting
GenesisCare Mater Hospital North Sydney New South Wales Recruiting
GenesisCare Bundaberg Bundaberg Queensland Recruiting
GenesisCare Southport Southport Queensland Recruiting
GenesisCare Tugun Tugun Queensland Recruiting
GenesisCare Hervey Bay Urraween Queensland Recruiting
GenesisCare St Andrew's Adelaide South Australia Recruiting
GenesisCare Bedford Park Bedford Park South Australia Recruiting
GenesisCare Wembley Wembley Washington Recruiting
GenesisCare Fiona Stanley Hospital Murdoch Western Austrailia Recruiting
GenesisCare Hollywood Nedlands Western Australia Recruiting
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit Calgary Alberta Recruiting
BC Cancer - Vancouver Island Centre Victoria British Columbia Recruiting
BCCA-Vancouver Island Cancer Centre Victoria British Columbia Not Yet Recruiting
QEII HSC - Nova Scotia Cancer Centre Halifax Nova Scotia Recruiting
Royal Victoria Regional Health Centre Barrie Ontario Recruiting
Juravinski Cancer Centre Hamilton Ontario Recruiting
London Regional Cancer Centre London Ontario Recruiting
Stronach (Southlake) Regional Health Centre Newmarket Ontario Recruiting
Algoma District Cancer Program Sault Ste. Marie Ontario Recruiting
Princess Margaret Hospital Toronto Ontario Recruiting
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre Toronto Ontario Recruiting
Windsor Regional Cancer Centre Windsor Ontario Recruiting
CSSS Champlain - Charles LeMoyne Greenfield Park Quebec Recruiting
CHUM - Centre Hospitalier de L'Université de Montréal Montreal Quebec Recruiting
McGill University Health Centre Montreal Quebec Recruiting
CHUQ-Pavillon Hotel-Dieu de Quebec Québec Quebec Recruiting
CHUS-Hopital Fleurimont Sherbrooke Quebec Recruiting
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ) Trois-Rivières Quebec Recruiting
Saskatoon Cancer Centre Saskatoon Saskatchewan Recruiting

More Ontario Clinical Oncology Group (OCOG) trials in Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05417516 on ClinicalTrials.gov ↗ ← All trials in Canada