A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment failure solid tumors are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.
详细描述
The goal of this study is to conduct a phase II clinical trial evaluating the safety and efficacy of combination of low temperature (40-43℃ range) hyperthermia and concurrent chemoradiotherapy (CCRT) in treatment failure solid tumors. There are 3 reasons of conducting this clinical trial. Firstly, it has been demonstrated that hyperthermia can enhance the efficacy of chemotherapy, radiotherapy or chemoradiotherapy in various cancers, with acceptable safety profiles. Secondly, the salvage outcomes for treatment failure solid tumors were frustrated. Thermal enhancement ratio (TER) was observed when using hyperthermia combining radiotherapy or chemotherapy. This strategy should be investigated in its efficacy in treating those failing from previous standard treatment and maybe several times of salvage therapy. Thirdly, biologically reciprocal complementation between hyperthermia, chemotherapy and radiotherapy was observed. The reason may be complicated, including theories involving hypoxia, immunomodulation and reperfusion ... etc. If the immunity microenvironment could be improved by addition of hyperthermia, an unexpected survival benefit as compared with the literature may be potentially demonstrated from this study.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20-85 years, with ECOG performance 0-
- •Treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any combinations.
- •Complete surgical excision is NOT feasible as salvage treatment for the recurrent or progressive tumor(s), or the patient does NOT agree to receive the surgical procedure.
- •Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
- •Measurable lesions by image examinations or endoscopy within 2 months.
- •The distribution of the lesions of interest does NOT exceed 20cm range.
- •The patient can tolerate implementation of cisplatin and taxotere weekly therapy, with respect to hematopoietic status, renal function, liver function, allergy and other potential adverse effects.
排除标准
- •Re-irradiation of 50Gy/22fx is considered NOT tolerable.
- •Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
- •The patient is participating in other clinical trials.
- •Future regular clinical follow-up is NOT possible.
- •The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
- •The patient has pacemakers.
研究组 & 干预措施
Radiation; Hyperthermia; Chemotherapy
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
干预措施: Radiation (Radiation)
Radiation; Hyperthermia; Chemotherapy
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
干预措施: Hyperthermia (Other)
Radiation; Hyperthermia; Chemotherapy
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
干预措施: Cisplatin (Drug)
Radiation; Hyperthermia; Chemotherapy
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
干预措施: Taxotere (Drug)
结局指标
主要结局
Tumor response rate
时间窗: 12 weeks
To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1).
次要结局
- Adverse events(up to 12 weeks)
- Late adverse events(up to 1 years)
- Time to Disease Progression(up to 5 years)