Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of courses delivered (relative dose intensity for adjuvant studies)
研究概览
简要总结
Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.
详细描述
All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients must have a cancer requiring chemotherapy or radiotherapy
排除标准
- •Inability to comply with study and/or follow-up procedures
- •Any contraindication per the FDA notice to the selected drugs
- •Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
研究组 & 干预措施
Arm 1
Standard of Care Treatment
干预措施: standard of care (Other)
Arm 2
Treatment Arm of a separate protocol (physician discretion)
干预措施: standard of care (Other)
结局指标
主要结局
Number of courses delivered (relative dose intensity for adjuvant studies)
时间窗: 6 months
次要结局
- Response rate(6 months)
- Progression- or disease-free survival (for metastatic disease)(6 months)
- Overall survival(6 months)
- Describe all adverse events of grade > 3 and Serious Adverse Events(6 months)
- Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment(6 months)