Radiation Therapy Schedules for Breast Cancer
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied.
Do I need to stop my current medications for this 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 idea that Radiation Therapy Schedules for Breast Cancer is an effective treatment?
The available research shows that hypofractionated radiation therapy (HFRT) is effective for treating breast cancer. Studies indicate that HFRT is a standard treatment for early-stage breast cancer, providing good plan quality and effectiveness. It also offers a shorter treatment time compared to traditional methods, making it more convenient for patients. Additionally, modern radiation therapy techniques, like image-guided radiotherapy, ensure precise delivery, which helps in achieving high local tumor control and maintaining a good quality of life. These advancements make HFRT a reliable option for breast cancer treatment.
12345What safety data exists for radiation therapy schedules in breast cancer treatment?
Several studies provide safety data for hypofractionated radiation therapy (HFRT) in breast cancer treatment. Research indicates that HFRT is as effective and safe as conventional radiation therapy, with studies reporting on dosimetric outcomes, acute toxicity, and local control. For example, a study on post-mastectomy HFRT reported on normal tissue exposure and acute toxicity. Another study from New Zealand found HFRT to be effective with manageable acute toxicity in early breast cancer. Additionally, a 10-year single institution experience confirmed the safety and effectiveness of HFRT, noting both acute and late toxicities. These findings suggest that HFRT is a viable and safe option for breast cancer treatment, although concerns about toxicity still exist.
678910Is Hypofractionated Radiation Therapy a promising treatment for breast cancer?
Yes, Hypofractionated Radiation Therapy is a promising treatment for breast cancer. It offers shorter treatment times and can be more convenient for patients. Studies have shown that it provides similar outcomes to traditional radiation therapy, making it a good option for many patients.
47111213Eligibility Criteria
This trial is for adults with invasive breast cancer who are planning or have had surgery and recommend radiation to lymph nodes near the breast. They must not be pregnant, have no other active cancers, and should not have received certain prior treatments that overlap with this study's area.Inclusion Criteria
I had cancer other than breast cancer, treated it fully, and now show no signs of that cancer.
My breast cancer is confirmed and falls within early to mid stages before spreading widely.
I am scheduled for a mastectomy and an axillary evaluation after preoperative radiation therapy.
Exclusion Criteria
I had breast cancer in my other breast before starting preoperative radiation.
I have signs of cancer spread to distant parts of my body after surgery.
I am pregnant and will undergo radiation therapy after surgery.
I am cognitively impaired and will undergo a brief exam before postoperative radiation.
I will have a cognitive assessment before my preoperative radiation therapy.
I am pregnant and receiving preoperative radiation therapy.
My breast cancer is at stage T4 and I am receiving preoperative radiation therapy.
My breast cancer has spread to nearby lymph nodes.
Participant Groups
The trial tests if a shorter 3-week course of radiation therapy to the lymph nodes is as effective in preventing cancer recurrence as the conventional 5-week course. It also examines side effects like arm swelling.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I: Hypofractionated Regional Nodal Irradiation (RNI)Experimental Treatment4 Interventions
Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Group II: Arm II: Standard Regional Nodal Irradiation (RNI)Active Control4 Interventions
Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Banner- MD Anderson Cancer CenterGilbert, AZ
Piedmont HealthcareAtlanta, GA
The Queen's Medical CenterHonolulu, HI
Cooper Hospital University Medical CenterCamden, NJ
More Trial Locations
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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.
Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. [2018]Hypofractionated radiation therapy (HypoRT) can potentially improve local control with a higher biological effect and shorter overall treatment time. Response, local control, toxicity rates, and survival rates were evaluated in patients affected by inoperable advanced stage non-small cell lung cancer (NSCLC) who received HypoRT.
Automated Hypofractionated IMRT treatment planning for early-stage breast Cancer. [2021]Hypofractionated whole-breast irradiation is a standard adjuvant therapy for early-stage breast cancer. This study evaluates the plan quality and efficacy of an in-house-developed automated radiotherapy treatment planning algorithm for hypofractionated whole-breast radiotherapy.
Surface-guided radiation therapy for breast cancer: more precise positioning. [2021]Hypofractionated radiation therapy for breast cancer requires highly precise delivery through the use of image-guided radiotherapy (IGRT). Surface-guided radiation therapy (SGRT) is being increasingly used for patient positioning in breast radiotherapy. We aimed to assess the role of SGRT for verification of breast radiotherapy and the tumour bed.
[Smarter Medicine in Radiation Oncology - current and proven treatment concepts offering the greatest possible benefit to cancer patients in clinical practice]. [2021]Smarter Medicine in Radiation Oncology - current and proven treatment concepts offering the greatest possible benefit to cancer patients in clinical practice Abstract. Modern procedures in radiation therapy with respect to indication, therapy planning and implementation of shorter treatment regimens result in high local tumor control and excellent quality of life in frequent and clinically relevant disease entities including breast and prostate cancer as well as bone metastases. In the adjuvant therapy for early breast cancer, a careful comparative analysis of the use of endocrine adjuvant treatment over five years versus postoperative radiation therapy over less than four weeks may result in omission of radiation treatment in a selected patient population. Partial breast irradiation, while treating the tumor bed only in low risk situations, and hypofractionated whole breast radiotherapy for patients with a higher risk profile for local recurrence, halved treatment time compared to 10 years ago, making adjuvant radiotherapy for patients with breast cancer more convenient. In patients with localized prostate cancer, the introduction of hypofractionated treatment regimens halved the number of daily fractions and current developments point towards a one-week outpatient therapy for locally limited disease using high precision stereotactic techniques and accurate therapy planning based on multifunctional imaging. Patients with bone metastases are more and more treated with a single fraction, high precision stereotactic radiotherapy (radiosurgery) with high analgesic potential and achieving long lasting local tumor control. These modern, often significantly shorter, radiotherapy treatment regimens not only result in an excellent treatment response and better quality of life for patients, but also include a better utilization of radiotherapy resources needing less treatment machines and thus helping to reduce costs in the Swiss healthcare system.
A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. [2022]Hypofractionated External Beam Radiotherapy (HFRT) is a relatively new adjuvant Radiotherapy (RT) schedule for breast cancers following breast conservation surgery and less commonly, following mastectomy. Here we report our experience on normal tissue exposure and acute toxicity of HFRT after mastectomy.
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 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 radiotherapy in breast cancer: a 10-year single institution experience. [2022]Moderately post-operative hypofractionated radiotherapy (HYPO-RT) for breast cancer is a safe and effective strategy as seen in large prospective trials. This study aimed to assess overall and disease-free survivals, local control, and acute and late toxicities in patients treated with HYPO-RT.
Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. [2018]Dose-escalated hypofractionated radiotherapy (hfrt) using intensity-modulated radiotherapy (imrt), with inclusion of the pelvic lymph nodes (plns), plus androgen suppression therapy (ast) in high-risk prostate cancer patients should improve patient outcomes, but acute toxicity could limit its feasibility.
Conventional Versus Different Hypofractionated Radiotherapy Dosage Schedules in Postmastectomy Advanced Breast Cancer. [2022]The standard treatment for advanced breast cancer is surgery consisting of breast-conserving surgery or modified radical mastectomy (MRM) postneoadjuvant chemotherapy followed by adjuvant radiation treatment (RT). Conventionally-fractionated whole breast irradiation has been the standard RT regimen, but recently shorter courses of hypofractionated whole breast or chest wall irradiation have been advocated for patient convenience and reduction in health-care costs and resources. Radiation is delivered through the same technique, but tumors receive a higher dose of radiation per treatment session with hypofractionation.
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.
[Debate about breast cancer: "Cons: Intraoperative radiotherapy"]. [2011]Early breast cancer incidence increases owing to mammography screening. Hypofractionated radiotherapy is more and more proposed in women with low local relapse risk breast cancer, especially accelerated partial breast irradiation. Various irradiation modalities have been reported: brachytherapy, intraoperative irradiation, 3D-conformal accelerated partial breast irradiation. We describe limitations of intraoperative irradiation and the advantages of alternative techniques.