Ultrahypofractionation Radiation Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.The names of the two study groups in this research study are:* Proton Radiation Therapy (PBT)* Conventional or "Photon" Radiation Therapy (XRT)
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that no cytotoxic therapy or radiotherapy can be used during the study's radiation therapy.
Is ultrahypofractionation radiation therapy generally safe for humans?
Proton beam therapy (PBT), a type of radiation treatment, has been studied for various cancers and is generally considered safe, with some studies showing minimal toxicity and reduced side effects compared to other radiation methods. However, more research is needed to fully understand its safety across different conditions.12345
How is ultrahypofractionation radiation therapy for breast cancer different from other treatments?
Ultrahypofractionation radiation therapy for breast cancer is unique because it uses proton beam therapy (PBT), which can provide better dose distribution and potentially reduce risks compared to standard photon radiation therapy. This approach is particularly beneficial for tumors with complex anatomy or those near sensitive tissues.23678
What data supports the effectiveness of the treatment Ultrahypofractionation Radiation Therapy for Breast Cancer?
Proton beam therapy (PBT), a component of the treatment, is known for achieving better dose distributions than standard photon radiation therapy, which may reduce risks in breast cancer treatment. However, clinical evidence specifically supporting its effectiveness in breast cancer is still lacking.23679
Who Is on the Research Team?
Rachel Jimenez, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with non-metastatic left-sided breast cancer needing radiation, including internal mammary lymph nodes treatment. It's also open to right-sided or unfavorable cardiac anatomy cases as determined by the study lead. Pregnant/breastfeeding individuals, those with conditions like scleroderma or chronic kidney disease, and patients on other investigational studies evaluating cardiac toxicity are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy
Participants receive either proton beam radiation therapy or conventional photon radiation therapy 1x daily for 5 days over 1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cardiac MRI, blood tests, and questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated Photon Radiation Therapy (XRT)
- Accelerated Proton Beam Radiation Therapy (PBT)
Accelerated Photon Radiation Therapy (XRT) is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
American Society of Clinical Oncology
Collaborator