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Trial Title:
Ultrahypofractionation and Normal Tissue Toxicity
NCT ID:
NCT05912231
Condition:
Breast Cancer
Breast Cancer Female
Breast Cancer Stage II
Breast Cancer Stage III
Myocardial Fibrosis
Conditions: Official terms:
Breast Neoplasms
Fibrosis
Conditions: Keywords:
Radiation Therapy
Photon Radiation Therapy
XRT
Proton Beam Radiation Therapy
PBT
Breast Cancer
Breast Cancer Female
Breast Cancer Stage II
Breast Cancer Stage III
Myocardial Fibrosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Accelerated Proton Beam Radiation Therapy (PBT)
Description:
per protocol
Arm group label:
Accelerated Proton Beam Radiation Therapy (PBT) Group
Intervention type:
Radiation
Intervention name:
Accelerated Photon Radiation Therapy (XRT)
Description:
per protocol
Arm group label:
Accelerated Photon Radiation Therapy (XRT) Group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years of age
- Non-metastatic Breast Cancer patients who are scheduled to receive conventional
left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal
mammary lymph nodes (IMNs)
- Prior chemotherapy is permitted
- Ability to understand and the willingness to sign a written informed consent
document
- No contraindication to MRI
- Patients with right-sided breast cancer or patients with left-sided patients not
requiring treatment to the IMNs, but where cardiac anatomy is determined to be
unfavorable by the study PI, will be considered eligible.
Exclusion Criteria:
- Person who is pregnant or breastfeeding.
- Patients receiving any other investigational agent will not be excluded from study
eligibility, unless the patient is already enrolled in an interventional study
evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during
radiation therapy.
- Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
- Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
Gender:
Female
Gender based:
Yes
Gender description:
All women of all races and ethnic groups are eligible for this trial.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Jimenez, MD
Phone:
617-726-8651
Email:
RBJIMENEZ@PARTNERS.ORG
Start date:
August 15, 2023
Completion date:
September 17, 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
American Society of Clinical Oncology
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05912231
