A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age50-120
SponsorOntario Clinical Oncology Group (OCOG)
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Whole Breast Irradiation (WBI)
RadiationThe dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Partial Breast Irradiation (PBI)
RadiationThe dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Treatment groups
910 Participants
are divided into 2 treatment groupsGroup A: Whole Breast Irradiation (WBI)Active comparator 1 intervention
Group B: Partial Breast Irradiation (PBI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Local Recurrence
Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast.
Time frame
Annually for 5 years post-randomization2
Patient Assessment Cosmesis at 3 years
Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS.
Time frame
3 and 5 years post-randomizationSecondary outcomes
1
Distant Disease Free Survival (DDSF)
Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain).
Time frame
Annually for 5 years post-randomization.2
Disease Free Survival (DFS)
Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death.
Time frame
Annually for 5 years post-randomization.3
Overall Survival
Time from randomization to death of any cause.
Time frame
3 years post-randomizaton.4
Radiation Toxicity
Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0.
Time frame
2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ontario Clinical Oncology Group (OCOG)
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov