Optimal Application Dose of Superficial Hyperthermia

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Study for Analysis of the Optimal Application Dose of Superficial Hyperthermia

Conditions
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Tumors

Intervention / Treatment
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* Other: Hyperthermal treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Hyperthermal treatment once per week | Other: Hyperthermal treatment<br>* Hyperthermal treatment one or three times per week for 60 minutes<br>|
| Active Comparator: 2<br>Hyperthermal treatment 3 times a week | Other: Hyperthermal treatment<br>* Hyperthermal treatment one or three times per week for 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission (Imaging / clinical) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, overall survival, Quality of life |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperthermia, superficial tumor treatment, superficial tumors