A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 18
- 主要终点
- The rate of surgical resection necessity by progressing necrosis
研究概览
简要总结
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
详细描述
Accidental extravasation of anthracyclines including doxorubicin and its derivative epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of any damaged tissue. Thus, the patient is subjected to major surgery causing substantial delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
Purpose
Primary:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients treated with anthracycline
- •Informed consent obtained from the patient.
- •Suspicion of anthracycline extravasation is defined as:
- •A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.
- •The presence of at least one of the following:
- •The Topotect infusion must be started <6 hours after the accident.
- •The patient must be at least 18 years of age.
- •Performance status (PS) ≤
- •Suspicion of anthracycline extravasation from a central venous access device. -
排除标准
- •Known allergy towards dexrazoxane.
- •Reasonable suspicion of extravasation by other compounds than anthracyclines through the same intravenous access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration.
- •AST, ALT, bilirubin, LDH, serum alkaline phosphatase >3 x upper normal value
- •Neutropenia and thrombocytopenia ≥ CTC grade 2
- •Pregnant or nursing women
- •Women of childbearing age and potential, where the patient does not agree to use an efficient contraceptive (e.g. birth control pill or an intra-uterine device for 3 months previous to start of the trial medication or diaphragm plus a spermicide).
结局指标
主要结局
The rate of surgical resection necessity by progressing necrosis
次要结局
未报告次要终点