Chemo-embolization for Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluate progression free survival
研究概览
简要总结
The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.
详细描述
This is a single site, single arm Phase II trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the U.S. Chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. Within UAB, the Investigators plan to recruit 48 patients to implement the intervention, within a two-year period. Progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up Head and Neck imaging (CT or MRI) interpreted by a Radiologist not involved in the study, per standard of care. Overall survival will be reported by the patients' Oncology team on a monthly basis. The trial endpoints will form the basis of how PFS and OS compare to historical outcomes in a similar cohort of patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •2.Stated willingness to comply with all study procedures and availability for the duration of the study
- •3.Male or female, aged 18 or older
- •4.Diagnosed with squamous cell carcinoma of the Head and Neck
- •5.Ability to undergo chemo-embolization
- •6.For females of reproductive potential: Negative pregnancy test at time of chemo-embolization
- •7.Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status.
- •8.Plan to undergo standard of care radiation and chemo- and/or immunotherapy.
排除标准
- •Medically unfit to undergo chemo-embolization
- •Treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.
研究组 & 干预措施
Chemo-embolization
Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Evaluate progression free survival
时间窗: 6 Months
Progression free survival is the length of time from the day of the chemo-embolization procedure that a patient lives with the disease but it does not get worse. Cumulative progression-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of progression-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.
次要结局
- Evaluate overall survival(2 Years)
- Evaluate oropharyngeal bleeding(2 years)
研究者
Jesse G. A. Jones, MD
Assistant Professor
University of Alabama at Birmingham