Proton Therapy for Lymph Nodes in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: 3D-Proton/Conventional plan or 3D-proton only; Radiation: Photon

• Registration Number: NCT01365845
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Study Start: 2012-04
• Primary Completion: 2014-03
• Results First Submitted: 2014-09-11
• Results First Submitted QC: 2014-12-03
• Results First Posted: 2014-12-05
• Status Verified: 2018-05
• Study Completion: 2018-05-23
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	3D-Proton/Conventional plan or 3D-proton only	3D-Proton/Conventional plan or 3D-proton only
1	Photon	Conventional photon plan

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Cardiac Function Markers	after treatment	Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.
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 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.

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States