A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with CCRT on recurrent head and neck cancer 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
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia for 40 minutes within 2hr after irradiation, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will be cisplatin 20mg/m2 and taxotere 10-12mg/m2 per week for 6 weekly cycles on the day before radiotherapy and hyperthermia treatment. The two chemotherapy agents will be given in only one day every week, according to the weekly dose. According to Gehan two-stage design, provided the estimated tumor response rate using this regimen is about 40% and objective tumor response is observed in ≥1 of the first 6 patients enrolled, α<0.05 will be achieved indicating a preliminary efficacy. Then the Gehan second stage will be started. With a set of 5% precision and an assumption of 10% dropout rate, 39 additional patients will be enrolled in the Gehan second stage depending on the actual number with tumor response in the Gehan first stage (totaling 45 patients when counting the first 6 in the Gehan first stage). The tumor response, adverse effects and various survival curves will be analyzed.
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 head and neck cancer, with histologically or clinically confirmed recurrence or progression after previous treatment of radiotherapy with 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.
- •There is NO other effective treatment option according to the evaluation of physicians.
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 or tattoos including much metal powder within hyperthermia field (not including metallic hemoclips with small area and few numbers).
- •The patient has pacemakers, electrocardiograph, defibrillator implanted, or adhesive skin patches including conductive metal.
- •The patients with ocular or cerebral disorders within hyperthermia field.
- •Tumor invasion of great or large vessels exists, or patients with any existing complications that may pose risks to hyperthermia treatment.
- •Patients who have difficulty with communication.
- •Other patients who are considered to have a contraindication to hyperthermia treatment.
研究组 & 干预措施
Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
干预措施: Radiation (Radiation)
Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
干预措施: Hyperthermia; Thermotron RF-8 (Device)
Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
干预措施: Cisplatin (Drug)
Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
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) using hyperthermia combined with CCRT for recurrent head and neck cancer.
次要结局
- Late adverse events(After 3 months)
- Adverse events(Within 3 months)