Clinical trial NCT01365845: Proton Therapy for Lymph Nodes in Breast Cancer
Official title: Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Proton Radiation
Breast Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
timeFrame: 2 weeks prior to starting radiation therapy.
Secondary outcomes:
measure: Secondary Dosimetric Endpoint
timeFrame: 2 weeks prior to starting radiation therapy.
measure: Assessment of Acute Side Effects
timeFrame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
measure: Assessment of Longterm Side Effects and Disease Specific End Points.
timeFrame: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
measure: Assessment of Cardiac Function Markers
timeFrame: after treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Julie A Bradley, MD
role: PRINCIPAL_INVESTIGATOR
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