Clinical trial NCT05912231: Ultrahypofractionation and Normal Tissue Toxicity
Official title: Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Breast Cancer Stage II
Breast Cancer Stage III
Myocardial Fibrosis
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Society of Clinical Oncology
First posted: 2023-06-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
timeFrame: Up to 7 months (pre-treatment period to 6 month follow up)
Secondary outcomes:
measure: Change in Global Longitudinal Strain (GLS) on CMR from Baseline
timeFrame: Up to 7 months (pre-treatment period to 6 month follow up)
measure: Stability of Cardiac Biomarkers from Baseline
timeFrame: Up to 7 months (pre-treatment period to 6 month follow up)
measure: Body Image Evaluation
timeFrame: Up to 13 months (pre-treatment period to 12 month follow up)
measure: Change in Shoulder Function from Baseline
timeFrame: Up to 13 months (pre-treatment period to 12 month follow up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: