Ultrahypofractionation and Normal Tissue Toxicity

Breast Cancer Clinical Trial

Official title: Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.

Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.

Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.

The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms
• Fibrosis
• Myocardial Fibrosis

• NCT number: NCT05912231
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Rachel Jimenez, MD
• Phone: 617-726-8651
• Email: RBJIMENEZ@PARTNERS.ORG
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Completion date: September 17, 2025