A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.
SECONDARY OBJECTIVES:
I. Assess complications associated with cesium 131 treatment in subjects with head and neck cancer.
OUTLINE:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer
- •Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively
- •Age: Subjects must be ≥ 18 years of age and ≤ 90 years old
- •Informed Consent: All subjects must be able to comprehend and sign a written informed consent document
排除标准
- •Subjects who are pregnant or may become pregnant
- •Unresectable tumor
- •Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study
研究组 & 干预措施
Cesium-131 Brachytherapy
Patients undergo brachytherapy using Cesium-131 during surgical resection
干预措施: Brachytherapy (Radiation)
Cesium-131 Brachytherapy
Patients undergo brachytherapy using Cesium-131 during surgical resection
干预措施: Cesium-131 (Drug)
Cesium-131 Brachytherapy
Patients undergo brachytherapy using Cesium-131 during surgical resection
干预措施: Conventional surgery (Procedure)
结局指标
主要结局
Disease free survival (DFS)
时间窗: Up to 24 months
Will assess the impact of cesium Cs 131 on DFS by comparing the cohort to a matched historical control cohort. The distribution of DFS will be estimated using the Kaplan-Meier and a stratified log rank test will be used to test for differences between cohorts. Adjustment for other potential confounders will be performed using stratified Cox proportional hazards regression
Incidence of toxicity
时间窗: Up to 90 days
Evaluated using the Radiation Therapy Oncology Group Common Toxicity Criteria Categories of risk include infection, wound breakdown, inability to heal, fistula formation, bleeding and need for further surgery.
次要结局
- Recurrence rate(Up to 24 months)
- Overall survival(Up to 24 months)
- Complication rate(Up to 24 months)
- Adverse event rate(Up to 30 days)