Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed carcinoma of the Cervix
- •FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish
- •clinical M0; except: involvement of para-aortic lymph nodes
- •Age ≥ 18 years
- •Informed consent of the patient
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 chemoradiation or deep regional hyperthermia
- •Metal implants (length > 2cm or dense clusters of marker clips in the pelvis)
- •Active or therapy-resistent bladder infections
- •Pre-existing or concommitant immunodeficiency Syndrome
- •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
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
干预措施: Radiation (Radiation)
Standard Arm
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
干预措施: brachytherapy (Radiation)
Standard Arm
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
干预措施: Cisplatin (Drug)
Standard Arm
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
干预措施: Hyperthermia (Other)
结局指标
主要结局
Overall survival
时间窗: 5 years
次要结局
- Disease free survival (local / distant / overall)(5 years)
- Safety by Toxicity assessment according to NCI CTCAE v4.0(5 years)