Proton Therapy for Lymph Nodes in Breast Cancer (BR01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01365845|
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : December 5, 2014
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Photon Radiation: 3D-Proton/Conventional plan or 3D-proton only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Therapy for Peripheral Lymph Nodes in Breast Cancer|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 23, 2018|
Active Comparator: 1
Conventional photon plan
50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
3D-Proton/Conventional plan or 3D-proton only
Radiation: 3D-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
- Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) [ Time Frame: 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 Dosimetric Endpoint [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: after treatment ]Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365845
|United States, Florida|
|University of Florida Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||Julie A Bradley, MD||University of Florida Proton Therapy Institute|