N/A
Completed N=18
Proton Therapy for Lymph Nodes in Breast Cancer
Source: ClinicalTrials.gov NCT01365845 ↗Enrolled (actual)
18
Serious AEs
33.3%
Results posted
Dec 2014
Primary outcomePrimary: Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) — 34.7; 2.7 % of heart receiving >= 5 Gray (Gy) — p=0.0078
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) |
34.7; 2.7 | 0.0078 sig |
| SECONDARY Secondary Dosimetric Endpoint |
— | — |
| SECONDARY Assessment of Acute Side Effects |
— | — |
| SECONDARY Assessment of Longterm Side Effects and Disease Specific End Points. |
— | — |
| SECONDARY Assessment of Cardiac Function Markers |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT01365845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.