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Ultrahypofractionation and Normal Tissue Toxicity

NCT05912231 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-13

No results posted yet for this study

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)

Conditions

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

Interventions

RADIATION

Accelerated Proton Beam Radiation Therapy (PBT)

per protocol

RADIATION

Accelerated Photon Radiation Therapy (XRT)

per protocol

Sponsors & Collaborators

Principal Investigators

  • Rachel Jimenez, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912231 on ClinicalTrials.gov