Register-Trial Based on an Agreement of Health Insurances With the Department of Radiation Therapy of the University Hospital Erlangen for the Application of Regional Hyperthermia in Bladder Cancer: Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
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
- •Age ≥ 18 years
- •Histologically confirmed bladder cancer
- •ECOG-performance status ≤ 2
- •Informed consent
排除标准
- •Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- •Cardiac Pacemaker
- •Myocardial infarction within the past 12 months
- •Congestive heart failure
- •Complete bundle branch block
- •New York Heart Association (NYHA) class III or IV heart disease
- •Disease that would preclude TUR, chemoradiation or deep regional hyperthermia
- •Metal implants (lenght > 2cm or dense clusters of marker clips in the pelvis)
- •Active or therapy-resistent bladder infections
- •Pre-existing or concommitant immunodeficiency Syndrom
- •Pregnant or lactating women
- •Patients not willing to use effective contraception during and up to 6 months after therapy
研究组 & 干预措施
Standard Arm
1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2)
Chemotherapy:
5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3
Chemotherapy:
Cisplatin 20mg/m^2; d1-5, 29-33
干预措施: Hyperthermia (Other)
Standard Arm
1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2)
Chemotherapy:
5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3
Chemotherapy:
Cisplatin 20mg/m^2; d1-5, 29-33
干预措施: Radiotherapy (Radiation)
Standard Arm
1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2)
Chemotherapy:
5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3
Chemotherapy:
Cisplatin 20mg/m^2; d1-5, 29-33
干预措施: Chemotherapy 5-Fluorouracil (Drug)
Standard Arm
1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2)
Chemotherapy:
5-Fluorouracil 600mg/m^2, civ 120h; d1-5, 29-3
Chemotherapy:
Cisplatin 20mg/m^2; d1-5, 29-33
干预措施: Chemotherapy Cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: Participants will be followed for up to 5 years after the end of therapy
Overall survival
次要结局
- Disease free survival(Participants will be followed for up to 5 years after the end of therapy)
- Bladder preservation rate(Participants will be followed for up to 5 years after the end of therapy)
研究者
Oliver J. Ott
Principle Investigator
University of Erlangen-Nürnberg Medical School