Proton Therapy for Lymph Nodes in Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Proton Therapy for Peripheral Lymph Nodes in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Photon
* Radiation: 3D-Proton/Conventional plan or 3D-proton only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Conventional photon plan | Radiation: Photon<br>* 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction<br>|
| Experimental: 2<br>3D-Proton/Conventional plan or 3D-proton only | Radiation: 3D-Proton/Conventional plan or 3D-proton only<br>* 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks prior to starting radiation therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks prior to starting radiation therapy. | 
| Assessment of Acute Side Effects | Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea. | Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks. | 
| 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. | 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter. | 
| Assessment of Cardiac Function Markers | Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment. | after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Radiation, Breast Cancer