Ultrahypofractionation Radiation Therapy for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Pregnancy, Breastfeeding, Chronic kidney disease, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
14678How 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.
12349Eligibility Criteria
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
I have had chemotherapy before.
I have right-sided breast cancer or left-sided with specific heart concerns as determined by the study lead.
I have breast cancer that has not spread and will receive radiation therapy to the left side or both sides, including the internal mammary lymph nodes.
+3 more
Exclusion Criteria
I cannot have gadolinium contrast due to a health condition like kidney disease.
I cannot receive radiotherapy due to certain health conditions.
Person who is pregnant or breastfeeding
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Radiation Therapy
Participants receive either proton beam radiation therapy or conventional photon radiation therapy 1x daily for 5 days over 1 week
1 week
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cardiac MRI, blood tests, and questionnaires
12 months
2 visits (in-person) at 6 and 12 months
Participant Groups
The study compares two types of radiation therapy for breast cancer: Proton Beam Radiation Therapy (PBT) and Conventional Photon Radiation Therapy (XRT). The goal is to see if PBT causes fewer heart changes than XRT in patients with left-sided breast cancer, using MRI imaging for assessment.
2Treatment groups
Experimental Treatment
Group I: Accelerated Proton Beam Radiation Therapy (PBT) GroupExperimental Treatment1 Intervention
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.
Group II: Accelerated Photon Radiation Therapy (XRT) GroupExperimental Treatment1 Intervention
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.
Accelerated Photon Radiation Therapy (XRT) is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Conventional Radiation Therapy for:
- Breast cancer
- Non-metastatic left sided breast cancer
🇪🇺 Approved in European Union as Photon Radiation Therapy for:
- Breast cancer
- Non-metastatic breast cancer
🇨🇦 Approved in Canada as X-Ray Radiation Therapy for:
- Breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital Cancer CenterBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
National Cancer Institute (NCI)Collaborator
American Society of Clinical OncologyCollaborator
References
Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. [2022]Proton beam therapy (PBT) is a potentially superior technology to photon radiotherapy for tumors with complex anatomy, those surrounded by sensitive tissues, and childhood cancers.
Proton Beam Therapy for Early Breast Cancer: A Systematic Review and Meta-analysis of Clinical Outcomes. [2023]Adjuvant proton beam therapy (PBT) is increasingly available to patients with breast cancer. It achieves better planned dose distributions than standard photon radiation therapy and therefore may reduce the risks. However, clinical evidence is lacking.
Patterns of Proton Beam Therapy Use in Clinical Practice between 2007 and 2019 in Korea. [2022]Proton beam therapy (PBT) is a state-of-the-art technology employed in radiotherapy (RT) for cancer patients. This study characterized how PBT has been used in clinical practice in Korea.
An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. [2018]Proton beam therapy (PBT) is a novel method for treating malignant disease with radiotherapy. The purpose of this work was to evaluate the state of the science of PBT and arrive at a recommendation for the use of PBT. The emerging technology committee of the American Society of Radiation Oncology (ASTRO) routinely evaluates new modalities in radiotherapy and assesses the published evidence to determine recommendations for the society as a whole. In 2007, a Proton Task Force was assembled to evaluate the state of the art of PBT. This report reflects evidence collected up to November 2009. Data was reviewed for PBT in central nervous system tumors, gastrointestinal malignancies, lung, head and neck, prostate, and pediatric tumors. Current data do not provide sufficient evidence to recommend PBT in lung cancer, head and neck cancer, GI malignancies, and pediatric non-CNS malignancies. In hepatocellular carcinoma and prostate cancer and there is evidence for the efficacy of PBT but no suggestion that it is superior to photon based approaches. In pediatric CNS malignancies PBT appears superior to photon approaches but more data is needed. In large ocular melanomas and chordomas, we believe that there is evidence for a benefit of PBT over photon approaches. PBT is an important new technology in radiotherapy. Current evidence provides a limited indication for PBT. More robust prospective clinical trials are needed to determine the appropriate clinical setting for PBT.
Proton beam therapy and concurrent chemotherapy for esophageal cancer. [2022]Proton beam therapy (PBT) is a promising modality for the management of thoracic malignancies. We report our preliminary experience of treating esophageal cancer patients with concurrent chemotherapy (CChT) and PBT (CChT/PBT) at MD Anderson Cancer Center.
Normofractionated and moderately hypofractionated proton therapy: comparison of acute toxicity and early quality of life outcomes. [2022]Data on the safety of moderately hypofractionated proton beam therapy (PBT) are limited. The aim of this study is to compare the acute toxicity and early quality of life (QoL) outcomes of normofractionated (nPBT) and hypofractionated PBT (hPBT).
Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial. [2018]Proton beam therapy (PBT) reduces normal organ dose compared to intensity modulated radiation therapy (IMXT) for prostate cancer patients who receive pelvic radiation therapy. It is not known whether this dosimetric advantage results in less gastrointestinal (GI) and genitourinary (GU) toxicity than would be expected from IMXT.
Proton Beam Radiotherapy and Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Final Results of a Phase 2 Study. [2022]Proton beam radiotherapy (PBT) has the potential to reduce toxic effects in the definitive management of locally advanced non-small cell lung cancer (NSCLC), but long-term prospective data are lacking.
Simulation study of dosimetric effect in proton beam therapy using concomitant boost technique for unresectable pancreatic cancers. [2018]The purpose of this study is to investigate the dose distribution of proton beam therapy (PBT) using a concomitant boost technique for unresectable pancreatic cancers.