A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Recruiting · NCT05417516 · Interventional (participants receive a specific treatment) · Lead sponsor: Ontario Clinical Oncology Group (OCOG)
View the official record on ClinicalTrials.gov →Interventions studied
Partial Breast Irradiation (PBI)Whole Breast Irradiation (WBI)
What this trial is about
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.
Who can take part
Age range
50 Years to 120 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- For inclusion in this study, patients must fulfill all of the following criteria:
- 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).
- Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- 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:
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size \>3cm in greatest diameter on pathological examination.
- 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
- Evidence of a DCIS component \> 3cm
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
Where it is running
30 locations listed.
- Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit - Calgary, Alberta, Canada
- BCCA-Vancouver Island Cancer Centre - Victoria, British Columbia, Canada
- GenesisCare Darlinghurst - Darlinghurst, New South Wales, Australia
- GenesisCare Hurstville - Hurstville, New South Wales, Australia
- GenesisCare Mater Hospital - North Sydney, New South Wales, Australia
- 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
- CHUM - Centre Hospitalier de L'Université de Montréal - Montreal, Quebec, Canada
- McGill University Health Centre - Montreal, Quebec, Canada
- CHUQ-Pavillon Hotel-Dieu de Quebec - Québec, Quebec, Canada
- CHUS-Hopital Fleurimont - Sherbrooke, Quebec, Canada
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières, Quebec, Canada
- GenesisCare Bundaberg - Bundaberg, Queensland, Australia
- GenesisCare Southport - Southport, Queensland, Australia
- GenesisCare Tugun - Tugun, Queensland, Australia
- GenesisCare Hervey Bay - Urraween, Queensland, Australia
- Saskatoon Cancer Centre - Saskatoon, Saskatchewan, Canada
- GenesisCare St Andrew's - Adelaide, South Australia, Australia
- GenesisCare Bedford Park - Bedford Park, South Australia, Australia
- GenesisCare Wembley - Wembley, Washington, Australia
- GenesisCare Fiona Stanley Hospital - Murdoch, Western Austrailia, Australia
- GenesisCare Hollywood - Nedlands, Western Australia, Australia