A Randomized Trial of Five Fraction Partial Breast Irradiation

Radiotherapy Clinical Trial

Official title: A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)

Status Recruiting

Clinical Trial 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 reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Clinical Trial 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 consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre. ;

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Cosmetic Outcome
• Radiotherapy

• NCT number: NCT05417516
• Study type: Interventional
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: Shelley Chambers, MA
• Phone: 905-928-8842
• Email: chamberss@hhsc.ca
• Status: Recruiting
• Phase: Phase 3
• Start date: November 20, 2023
• Completion date: November 2031