Breast Cancer
Conditions
Keywords
Proton Radiation, Breast Cancer
Brief summary
The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.
Interventions
RADIATIONPhoton
50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
RADIATION3D-Proton/Conventional plan or 3D-proton only
50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion. * Patients must have undergone either mastectomy or breast conservation surgery. * Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative. * Patient must require peripheral lymph node radiation per physician discretion.
Exclusion criteria
* Evidence of distant metastasis (M1). * Prior radiotherapy to the area of interest. * Prior history of cardiovascular disease per physician discretion. * Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years. * Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) | 2 weeks prior to starting radiation therapy. | A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Dosimetric Endpoint | 2 weeks prior to starting radiation therapy. | Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax. |
| Assessment of Acute Side Effects | Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks. | Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea. |
| Assessment of Longterm Side Effects and Disease Specific End Points. | 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter. | Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies. Analyze local control, progression-free survival, and overall survival. |
| Assessment of Cardiac Function Markers | after treatment | Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breast Patients Planned With Both Proton & Conventional Plans Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.
Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Breast Patients Planned With Both Proton & Conventional Plans |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 52 Years |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 18 |
| serious Total, serious adverse events | 6 / 18 |
Outcome results
Primary
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.
Time frame: 2 weeks prior to starting radiation therapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Conventional Photon Plan | Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) | 34.7 % of heart receiving >= 5 Gray (Gy) |
| 3D-Proton/Conventional Plan or 3D-proton Only | Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) | 2.7 % of heart receiving >= 5 Gray (Gy) |
p-value: 0.0078Wilcoxon (Mann-Whitney)
Secondary
Assessment of Acute Side Effects
Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.
Time frame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
Secondary
Assessment of Cardiac Function Markers
Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.
Time frame: after treatment
Secondary
Assessment of Longterm Side Effects and Disease Specific End Points.
Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies. Analyze local control, progression-free survival, and overall survival.
Time frame: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
Secondary
Secondary Dosimetric Endpoint
Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.
Time frame: 2 weeks prior to starting radiation therapy.