Pilot Study of a Catheter-based Ultrasound Hyperthermia System
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
- Proportion of patients treated according to the specified temperature and timing criteria.
研究概览
简要总结
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.
详细描述
OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.
After completion of study therapy, patients are followed at 1 and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 who are to be given HDR brachytherapy for treatment of solid tumor of the following:
- •Cervical cancer Stage III or IV OR
- •Prostate cancer (with rising prostate specific antigen after prior local therapy)
- •Age >=18 years
- •Eligible for brachytherapy as determined per clinical standard of care.
- •Ability to give written informed consent and willingness to comply with the requirements of the protocol
排除标准
- •Patients who are not candidates for HDR brachytherapy
- •Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
结局指标
主要结局
Proportion of patients treated according to the specified temperature and timing criteria.
时间窗: Up to 4 weeks
The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions
Frequency of treatment-related toxicities by accrual plan
时间窗: Up to 3 months
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
Frequency of treatment-related toxicities by treatment type
时间窗: Up to 3 months
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
次要结局
- Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)(Up to 4 weeks)
- Median temperature (T50)(Up to 4 weeks)
- Average maximum prostate temperature (Tmax)(Up to 4 weeks)
- Minimum temperature (Tmin)(Up to 4 weeks)
- Number of times temperature exceeded by 90% of the measured temperature points (T90)(Up to 4 weeks)
研究者
I-Chow Hsu
Professor, Radiation Oncology
University of California, San Francisco