Hypofractionated Radiotherapy for Breast Cancer (RHEAL Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ontario Clinical Oncology Group (OCOG)
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.
What safety data exists for hypofractionated radiotherapy in breast cancer treatment?Long-term randomized trials have confirmed the safety and efficacy of hypofractionated radiotherapy for early breast cancer, using doses of 40-42.6 Gy over 3 weeks. It is considered a standard of care in the UK and parts of Canada. Studies have assessed toxicities and outcomes, showing it is as safe as conventional treatment, though concerns about toxicity persist. Research also highlights the need for careful planning and monitoring to manage potential increased toxicity.256810
Is locoregional radiation treatment a promising treatment for breast cancer?Yes, locoregional radiation treatment, specifically hypofractionated radiotherapy, is promising for breast cancer. It is effective and safe, offering similar outcomes to traditional methods but in a shorter time and at a lower cost. It is already a standard treatment in some countries and is gaining popularity due to its convenience and effectiveness.135712
What data supports the idea that Hypofractionated Radiotherapy for Breast Cancer is an effective treatment?The available research shows that hypofractionated radiotherapy is effective for treating breast cancer. Long-term studies have confirmed its safety and effectiveness, especially for early breast cancer, with treatment lasting about 3 weeks. It is considered a standard treatment in the UK and parts of Canada. Compared to traditional methods, hypofractionated radiotherapy is just as effective but more convenient and less expensive, making it a popular choice for patients.457911
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, neoadjuvant endocrine therapy is not allowed, and extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.
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 haven't had cancer other than non-melanoma skin cancer or treated in-situ carcinoma in the last 5 years.
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 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.
I am under 18 years old.
Treatment Details
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.