NL-OMON47640已完成2 期
IMAGE GUIDED SURGERY FOR MARGIN ASSESSMENT OF HEAD & NECK CANCER USING CETUXIMAB-IRDYE800CW CONJUGATE (ICON) - ICO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1) Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to
- •undergo surgical resection as decided by the Multi-Disciplinary Head & Neck
- •Tumor Board of the UMCG.
- •2) Age * 18 years
- •3) Written informed consent
- •4) Adequate potential for follow up
- •5) Acceptable hematologic status, kidney function, and liver function, as
- •standard surgery protocol requires.
排除标准
- •1) Medical or psychiatric conditions that compromise the patient*s ability to
- •give informed consent
- •2) Concurrent uncontrolled medical conditions.
- •3) Received an investigational drug within 30 days prior to the dose of
- •cetuximab-IRDye800CW
- •4) Tumors at sites of which the surgeon would assess that in vivo imaging would
- •not be feasible
- •5) Had within 6 months prior to enrollment: myocardial infarction,
- •cerebrovascular accident, uncontrolled cardiac heart failure, significant liver
- •disease, unstable angina
- •6) Inadequately controlled hypertension with or without current
- •antihypertensive medications.
- •7) History of infusion reactions to cetuximab or other monoclonal antibody
- •8) Pregnant or lactating women. Documentation of a negative pregnancy test must
- •be available for women of childbearing potential. Woman of childbearing
- •potential are premenopausal women with intact reproductive organs and women
- •less than two years after menopause.
- •9) Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in
- •males or greater than 450 ms in females)
- •10) Lab values that in the opinion of the primary surgeon would prevent
- •surgical resection
- •11) Patients receiving Class IA (quinidine, procainamide) or Class III
- •(dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- •12) Magnesium, potassium and calcium deviations that might lead to cardiac
- •rhythm (grade II or higher deviations by CTCAE).
- •13) Life expectancy < 12 weeks
- •14) Karnofsky performance status < 70%
研究者
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