Hypofractionated Radiotherapy for Breast Cancer
(RHEAL Trial)
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ontario Clinical Oncology Group (OCOG)
Must not be taking: Neoadjuvant endocrine therapy
Disqualifiers: Age < 18, T4/N3 stages, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial compares two radiation schedules for breast cancer patients to see if a shorter, higher-dose treatment is as effective as a longer, lower-dose one.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Hypofractionated Radiotherapy for Breast Cancer?
Research shows that hypofractionated radiotherapy, which uses higher doses of radiation over a shorter period, is safe and effective for treating early breast cancer. It is considered a standard treatment in the UK and parts of Canada, and studies have shown it to be as effective as longer courses of radiation, with the added benefits of being more convenient and less costly.12345
Is hypofractionated radiotherapy safe for humans?
Research shows that hypofractionated radiotherapy is generally safe for treating early breast cancer, with long-term studies confirming its safety and effectiveness. It is considered a standard treatment in the UK and parts of Canada, although there are some concerns about potential increased side effects.16789
How is hypofractionated radiotherapy different from other breast cancer treatments?
Hypofractionated radiotherapy for breast cancer involves giving fewer, larger doses of radiation over a shorter period, typically 3 weeks, compared to conventional treatments. This approach is considered safe and effective, with similar outcomes to traditional methods, and is already a standard of care in some regions like the UK and parts of Canada.15101112
Eligibility Criteria
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.Inclusion Criteria
My cancer has not spread to other parts of my body.
I have recently been diagnosed with breast cancer and have undergone surgery.
I am eligible for targeted radiation therapy after my surgery.
Exclusion 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.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either conventional or hypofractionated locoregional radiotherapy
1-3 weeks
5-15 visits (in-person)
Follow-up
Participants are monitored for lymphedema, radiation toxicity, and other outcomes
5 years
Annual visits (in-person)
Long-term follow-up
Participants are assessed for breast cancer recurrence, new second cancers, and overall survival
5 years
Treatment Details
Interventions
- Locoregional radiation treatment (Radiation)
Trial OverviewThe 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.
Participant Groups
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
Locoregional radiation treatment is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Locoregional Radiation Therapy for:
- Breast cancer
- Node-positive breast cancer
🇺🇸 Approved in United States as Locoregional Radiation Therapy for:
- Breast cancer
- Node-positive breast cancer
🇨🇦 Approved in Canada as Locoregional Radiation Therapy for:
- Breast cancer
- Node-positive breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Cancer - Vancouver CentreVancouver, Canada
BC Cancer - Centre for the NorthPrince George, Canada
The Ottawa Hospital Regional Cancer CentreOttawa, Canada
Sunnybrook Health Sciences Centre - Odette Cancer CentreToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Ontario Clinical Oncology Group (OCOG)Lead Sponsor
References
Role of hypofractionated radiotherapy in breast locoregional radiation. [2018]Long-term results of randomised trials have confirmed the safety and efficacy of hypofractionated radiotherapy using approximately 2.6 Gy per fraction to lower total doses of 40-42.6 Gy delivered over 3 weeks, for postoperative treatment of early breast cancer. In these trials, hypofractionated radiotherapy was predominantly used for breast only treatment, while there are fewer trials that specifically examined hypofractionated radiotherapy to the breast plus regional nodes. Hypofractionated locoregional radiation is considered a standard of care in the United Kingdom and in some parts of Canada. We aim to review the radiobiology and normal tissue effects of hypofractionated locoregional radiation and to summarize available published clinical experiences using this treatment strategy as adjuvant therapy after breast conserving surgery or mastectomy for women with early breast cancer.
Hypofractionated Regional Nodal Irradiation for Women With Node-Positive Breast Cancer. [2022]To evaluate the effect of hypofractionated radiation therapy (HFRT) of the breast/chest wall and regional nodes on overall survival (OS), disease-free survival (DFS), locoregional control and on treatment-related toxicity in patients with breast cancer and nodal involvement.
Hypofractionated Radiation Therapy (HFRT) of Breast/Chest Wall and Regional Nodes in Locally Advanced Breast Cancer: Toxicity Profile and Survival Outcomes in Retrospective Monoistitutional Study. [2022]To evaluate the efficacy and safety of hypofractionated radiation therapy (HFRT) of the breast/chest wall and regional nodes in patients with locally advanced breast cancer and positive lymph nodes.
Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. [2022]Large randomized trials have established the noninferiority of shorter courses of "hypofractionated" radiation therapy (RT) to the whole breast compared to conventional courses using smaller daily doses in the adjuvant treatment of selected breast cancer patients undergoing lumpectomy. Hypofractionation is more convenient and less costly. Therefore, we sought to determine uptake of hypofractionated breast RT over time.
Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]Hypofractionated radiotherapy for breast cancer is becoming increasingly important. The scientific background of this development as well as the introduction of the simultaneous integrated boost to the primary tumor region in this context are discussed here.
Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. [2022]Randomized trials have established the long-term safety and efficacy of hypofractionated whole-breast radiotherapy, but little is known about the acute toxic effects experienced by patients treated with hypofractionation as compared with conventional fractionation, particularly in real-world settings and from the patient's own perspective.
Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. [2018]High-quality evidence supports that hypofractionated radiation treatment (HFRT) is as effective and safe in early breast cancer as conventionally fractionated radiation treatment. HFRT with fewer treatments has potential benefits for both patients and radiation departments. Despite this, concerns about local control and toxicity with HFRT persist, such that many eligible patients do not receive HFRT. The local recurrence rates and acute toxicity after HFRT was analyzed in our center in Christchurch, New Zealand.
Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]Hypofractionation is now becoming the standard of care in breast irradiation. The aim of this study was to assess the toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy (HFRT).
What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? [2018]Hypofractionated radiotherapy regimens have become increasingly popular in breast cancer, particularly in the UK and Canada. However, there are some potential problems inherent to providing such regimens, such as the concern of increased toxicity. In this article we discuss the planning and dosimetry and requirements for hypofractionated radiotherapy in breast cancer and make recommendations both for the planning process and for treatment monitoring.
Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]Hypofractionated radiation refers to the use of fewer, larger-dose radiation treatments that are usually given over a shorter time period compared to conventional radiation fraction sizes. Randomized trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation. For a higher-risk population for local recurrence, a phase 3 trial by the Radiation Therapy Oncology Group (RTOG) is currently studying hypofractionated WBI with a concurrent tumor bed boost over 3 weeks. Accelerated partial breast irradiation limits radiation to the region of the tumor bed for 1-3 weeks and is the subject of an ongoing randomized trial by the National Surgical Breast and Bowel Project and RTOG. Questions remain for hypofractionation about optimal patient selection, radiation techniques, and the risk of late toxicity. But results from current trials could make hypofractionation more widely accepted for patients with early-stage breast cancer.
Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]Application of hypofractionated radiotherapy (HFRT) is growing in patients with breast cancer (BC). This study aimed to explore a real-world practice of HFRT in early and locally advanced BC.
Clinical experience using hypofractionated radiation schedules in breast cancer. [2022]Hypofractionation is attractive for whole- or partial-breast irradiation because it permits treatment to be given with fewer fractions in a shorter period of time and at less cost. A number of cohort studies suggest that hypofractionation may be given to the whole breast safely and with good local control. Recent randomized trials have confirmed that hypofractioned whole-breast irradiation is equivalent to more conventional whole-breast irradiation with respect to local recurrence and cosmetic outcome. Recently, there has been a renewed interest in hypofractionation for the delivery of partial-breast irradiation using a number of techniques including high-dose rate brachytherapy, 3-dimensional conformal radiation using external-beam techniques, and intraoperative therapy. Early cohort studies report good local control and acceptable morbidity. Randomized trials are now underway to compare this approach to conventional whole-breast irradiation.