Status:
RECRUITING
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Conditions:
Breast Neoplasm Female
Radiotherapy
Eligibility:
FEMALE
50-120 years
Phase:
PHASE3
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 red...
Detailed Description
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and cons...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT05417516
Start Date
November 20 2023
End Date
November 1 2031
Last Update
September 24 2025
Active Locations (26)
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1
GenesisCare Hurstville
Hurstville, New South Wales, Australia, 2220
2
GenesisCare Mater Hospital
North Sydney, New South Wales, Australia, 2060
3
GenesisCare Bundaberg
Bundaberg, Queensland, Australia, 4670
4
GenesisCare Southport
Southport, Queensland, Australia, 4215