A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
NCT ID: NCT05417516
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
910 participants
INTERVENTIONAL
2023-11-20
2031-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Whole Breast Irradiation (WBI)
26 Gy in 5 fractions to the whole breast
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)
26 Gy in 5 fractions to the tumour bed with a margin of normal tissue
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).
Interventions
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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).
Eligibility Criteria
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Inclusion 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
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.
50 Years
120 Years
FEMALE
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Timothy Whelan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre and McMaster University
Locations
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GenesisCare Hurstville
Hurstville, New South Wales, Australia
GenesisCare Mater Hospital
North Sydney, New South Wales, Australia
GenesisCare Bundaberg
Bundaberg, Queensland, Australia
GenesisCare Southport
Southport, Queensland, Australia
GenesisCare Tugun
Tugun, Queensland, Australia
GenesisCare Hervey Bay
Urraween, Queensland, Australia
GenesisCare St Andrew's
Adelaide, South Australia, Australia
GenesisCare Wembley
Wembley, Washington, Australia
GenesisCare Fiona Stanley Hospital
Murdoch, Western Austrailia, Australia
GenesisCare Hollywood
Nedlands, Western Australia, Australia
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
Calgary, Alberta, Canada
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
QEII HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Stronach (Southlake) Regional Health Centre
Newmarket, Ontario, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, Canada
CSSS Champlain - Charles LeMoyne
Greenfield Park, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
Trois-Rivières, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Maureen Nolan
Role: primary
Other Identifiers
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OCOG-2022-RAPID2
Identifier Type: -
Identifier Source: org_study_id
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