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Hypofractionated Radiotherapy for Breast Cancer (RHEAL Trial)
Phase 3
Recruiting
Led By Timothy Whelan
Research Sponsored by Ontario Clinical Oncology Group (OCOG)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of metastatic disease
Newly diagnosed invasive carcinoma of the breast treated with definitive surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 3 years post randomization
Awards & highlights
RHEAL Trial 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.
Who is the study for?
This trial is for adults with newly diagnosed node-positive breast cancer who've had surgery and need radiotherapy, but haven't spread to other body parts. It's not for those with recent non-breast cancers (except certain skin cancers), previous chest radiation, severe diseases like scleroderma or serious heart/lung conditions, under 18s, advanced tumor stages T4/N3, arm swelling after surgery, pregnant/breastfeeding women, or if they can't follow up for 5 years.Check my eligibility
What is being tested?
The study compares two ways of giving radiotherapy: the standard method over 3 weeks versus a shorter one-week course. The goal is to see if the short course works just as well without making patients come in for treatment as often.See study design
What are the potential side effects?
Radiotherapy may cause side effects such as skin irritation at the treatment site, fatigue during and after treatment sessions, potential development of lymphedema (swelling) in treated areas and rarely more serious issues involving heart or lung function.
RHEAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to other parts of my body.
Select...
I have recently been diagnosed with breast cancer and have undergone surgery.
Select...
I am eligible for targeted radiation therapy after my surgery.
RHEAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 3 years post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 3 years post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lymphedema
Secondary outcome measures
Arm mobility
Breast cancer recurrence
Health Care Resource Utilization
+6 moreRHEAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Hypofractionation for locoregional radiotherapy
Group II: ControlActive Control1 Intervention
Conventional fractionation for locoregional radiotherapy
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Who is running the clinical trial?
Ontario Clinical Oncology Group (OCOG)Lead Sponsor
62 Previous Clinical Trials
41,297 Total Patients Enrolled
16 Trials studying Breast Cancer
9,118 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer or DCIS on the same side treated with radiation before.My cancer is at an advanced stage, affecting nearby tissues or lymph nodes.I haven't had cancer other than non-melanoma skin cancer or treated in-situ carcinoma in the last 5 years.I am planning to have or have had breast reconstruction.I am receiving hormone therapy before surgery.I have not had radiation on the same side breast or chest wall, nor do I have severe lung, heart disease, or scleroderma.I have had breast cancer in both breasts at the same time or in the past.I have swelling in the same side arm or chest as my cancer.My cancer has not spread to other parts of my body.I am under 18 years old.You live too far away to easily come back for check-up visits.I have recently been diagnosed with breast cancer and have undergone surgery.You have medical conditions that would make it difficult for you to come back for check-ups for 5 years.I am eligible for targeted radiation therapy after my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Experimental
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project being conducted at different locations within the city?
"Presently, this trial is running in 15 locations. These locations include, but are not limited to, Calgary, Edmonton and Toronto. If you are considering participating in this trial, please choose the location nearest you to avoid extensive travel."
Answered by AI
What are some potential risks associated with Locoregional radiation treatment - Hypofractionation?
"This particular form of radiation treatment has been studied enough to warrant a score of 3 on our team's safety scale. This is a Phase 3 trial, which means that there is both efficacy and safety data supporting its use."
Answered by AI
What is the maximum number of enrollees for this experiment?
"That is correct. The clinical trial, as indicated on clinicaltrials.gov, is still recruiting patients. The trial was posted on February 10th, 2021 and was last updated on October 4th, 2022. The study needs 588 participants from 15 different sites."
Answered by AI
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