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

RecruitingPhase 3

Sponsor: Ontario Clinical Oncology Group (OCOG)

Conditions: Breast Neoplasm Female, Radiotherapy, Cosmetic Outcome

Interventions: Whole Breast Irradiation (WBI), Partial Breast Irradiation (PBI)

Countries: Australia, Canada

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 overview

Sex: FEMALE

Age: 50 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (30)

Darlinghurst, New South Wales, Australia
Hurstville, New South Wales, Australia
North Sydney, New South Wales, Australia
Bundaberg, Queensland, Australia
Southport, Queensland, Australia
Tugun, Queensland, Australia
Urraween, Queensland, Australia
Adelaide, South Australia, Australia
Bedford Park, South Australia, Australia
Wembley, Washington, Australia
Murdoch, Western Austrailia, Australia
Nedlands, Western Australia, Australia
Calgary, Alberta, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada