Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.
研究概览
简要总结
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
详细描述
High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 years of age;
- •Localized or metastatic osteosarcoma;
- •Adequate renal function (GFR > 70 ml/1.73m2) prior to each cycle;
- •No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
- •Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.
排除标准
- •Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
- •Pregnant females
- •Breastfeeding females
研究组 & 干预措施
HDMTX
This is a single arm study. All subjects enrolled in the study will be in this arm.
干预措施: High Dose Methotrexate (Drug)
结局指标
主要结局
The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.
时间窗: 9 months
Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.
次要结局
未报告次要终点
研究者
Abha Gupta
Staff Physician
The Hospital for Sick Children