Optimal Application Dose of Superficial Hyperthermia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Hyperthermal treatment once per week |
Other: Hyperthermal treatment
Hyperthermal treatment one or three times per week for 60 minutes
|
| Active Comparator: 2 Hyperthermal treatment 3 times a week |
Other: Hyperthermal treatment
Hyperthermal treatment one or three times per week for 60 minutes
|
Outcome Measures
Primary Outcome Measures
- Complete remission (Imaging / clinical) [5 years]
Secondary Outcome Measures
- Progression-free survival, overall survival, Quality of life [5 years]
Eligibility Criteria
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
-
Cumulative equivalent minutes 42°C T75
Exclusion Criteria:
-
Pregnancy
-
Pace maker
-
Metal implants
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiotherapy University Hospital Mannheim | Mannheim | Germany | 68167 |
Sponsors and Collaborators
- Universitätsmedizin Mannheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA HT-PR 01