A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Recruiting
Phase 3
Interventional Study
Breast Neoplasm Female
Radiotherapy
Cosmetic Outcome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 120
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 910 (estimated)
- Sponsor
- Ontario Clinical Oncology Group (OCOG) · Other
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About This Trial
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.
Trial Locations
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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 microscopi…
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