Trials / Active Not Recruiting
Active Not RecruitingNCT05912231
Ultrahypofractionation and Normal Tissue Toxicity
Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Accelerated Proton Beam Radiation Therapy (PBT) | per protocol |
| RADIATION | Accelerated Photon Radiation Therapy (XRT) | per protocol |
Timeline
- Start date
- 2023-08-15
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2023-06-22
- Last updated
- 2025-11-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05912231. Inclusion in this directory is not an endorsement.