Optimal Application Dose of Surface Hyperthermia
Conditions: official terms
Conditions: Keywords
Hyperthermia, superficial tumor treatment, superficial tumors
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Hyperthermal treatment
Type: Other
Overall Status
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 acedotic, 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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

- CEM 42°C T75

Exclusion Criteria:

- Pregnancy

- Pace maker

- Metal implants
Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany
Status: Recruiting
Contact: Frederik Wenz, Prof. Dr. med. - 00496213834960 - frederik.wenz@medma.uni-heidelberg.de
Start Date
January 2008
Completion Date
December 2011
Universitätsmedizin Mannheim
Universitätsmedizin Mannheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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