Locoregional radiation treatment - Hypofractionation for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Cancer+2 MoreLocoregional radiation treatment - Hypofractionation - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a shorter, more intense course of radiation therapy is as effective as the standard 3-week course for people with node positive breast cancer.

Eligible Conditions
  • Breast Cancer
  • Radiotherapy
  • Lymphedema

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 1 and 3 years post randomization

Year 3
Arm mobility
Perception of breast cosmesis
3 years post randomization
Lymphedema
Year 5
Breast cancer recurrence
Mortality
Year 3
Patient Costs
Patient Quality of Life with respect to daily health and activities
Perception of lymphedema
Year 5
Radiation toxicity
Year 5
Health Care Resource Utilization

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control
1 of 2
Experimental
1 of 2

Active Control

Experimental Treatment

588 Total Participants · 2 Treatment Groups

Primary Treatment: Locoregional radiation treatment - Hypofractionation · No Placebo Group · Phase 3

Experimental
Radiation
Experimental Group · 1 Intervention: Locoregional radiation treatment - Hypofractionation · Intervention Types: Radiation
Control
Radiation
ActiveComparator Group · 1 Intervention: Locoregional radiation treatment - Conventional fractionation · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 and 3 years post randomization

Who is running the clinical trial?

Ontario Clinical Oncology Group (OCOG)Lead Sponsor
60 Previous Clinical Trials
20,075 Total Patients Enrolled
15 Trials studying Breast Cancer
8,766 Patients Enrolled for Breast Cancer
Timothy WhelanPrincipal InvestigatorJuravinski Cancer Centre, McMaster University, Hamilton
1 Previous Clinical Trials
2,140 Total Patients Enrolled
1 Trials studying Breast Cancer
2,140 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.
You have not received neoadjuvant chemotherapy.
You have a newly diagnosed invasive carcinoma of the breast.
Patients with N1mi are eligible.
Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive
You have no evidence of metastatic disease.