Optimal Application Dose of Superficial Hyperthermia
只有注册用户可以翻译文章
登陆注册
链接已保存到剪贴板
状态
赞助商
Universitätsmedizin Mannheim
临床试验: NCT00766233
BioSeek: nct00766233
关键词
抽象
Hyperthermia - a warming of the tumor at 42-43 ° C - in combination with radiation and / or chemotherapy is a proven method of treatment for malignant tumors. The amplification of the effect of radiotherapy and various chemotherapeutic agents (platinum analogues, nitrogen-Lost derivatives, cytotoxic antibiotics) is experimentally demonstrated. Randomized clinical trials have shown a better chance of survival and better local tumor control without increasing the toxicity of combined treatment especially also in children's tumors. The combination of hyperthermia and radiation therapy is more effective than radiotherapy alone. Hyperthermal temperatures increase blood circulation in tumors as a response to stimulation with heat. Tumor tissue, having a minor circulation and being acidotic, is resistant to radiotherapy, but sensitive to hyperthermia, while tumor with a high blood flow is sensitivity to radiation. This positive interaction is a compelling reason for the combination of hyperthermia and ionized radiation.
Hyperthermia, in combination with chemotherapy, increases the concentration of cytostatics in the tumor region, raising blood flow caused by warmth. In addition, hyperthermia increases toxicity of drugs in cells, being normally resistant to many drugs. Hyperthermia can synergistically be combined with chemotherapy treating "high risk" - tumors with curative intention.
In addition to the clinical use of surface hyperthermia (BSD 500 - O), with appropriate treatment of tumors up to 3 cm deep from the surface of the body with established indications and palliative indication in advanced stages of cancer, a prospective, randomized study with quality-controlled thermometry shall establish the optimal sequence of Hyperthermia in combination with irradiation. Therefore the treatment sequence of once per weeks is compared to a sequence of three times per week.
日期
最后验证: | 12/31/2015 |
首次提交: | 10/01/2008 |
提交的预估入学人数: | 10/01/2008 |
首次发布: | 10/02/2008 |
上次提交的更新: | 01/14/2016 |
最近更新发布: | 01/17/2016 |
实际学习开始日期: | 12/31/2007 |
预计主要完成日期: | 12/31/2015 |
预计完成日期: | 01/31/2016 |
状况或疾病
Tumors
干预/治疗
Other: Hyperthermal treatment
相
相 3
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: 1 Hyperthermal treatment once per week | |
Active Comparator: 2 Hyperthermal treatment 3 times a week |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Surficial tumors (< 3-4 cm) - ≥ 18 years - Karnofsky Index > 60 - No other treatment in between 30 d, applicable radiation dose min.30 Gy - Cumulative equivalent minutes 42°C T75 Exclusion Criteria: - Pregnancy - Pace maker - Metal implants |
结果
主要结果指标
1. Complete remission (Imaging / clinical) [5 years]
次要成果指标
1. Progression-free survival, overall survival, Quality of life [5 years]