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Optimal Application Dose of Superficial Hyperthermia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim Identifier:
First received: October 2, 2008
Last updated: January 15, 2016
Last verified: January 2016

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 Intervention Phase
Tumors Other: Hyperthermal treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study for Analysis of the Optimal Application Dose of Superficial Hyperthermia

Resource links provided by NLM:

Further study details as provided by Frederik Wenz, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Complete remission (Imaging / clinical) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Progression-free survival, overall survival, Quality of life [ Time Frame: 5 years ]

Enrollment: 17
Study Start Date: January 2008
Estimated Study Completion Date: February 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00766233

Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

Responsible Party: Frederik Wenz, Prof. Dr. med. Wenz, Universitätsmedizin Mannheim Identifier: NCT00766233     History of Changes
Other Study ID Numbers: MA HT-PR 01
Study First Received: October 2, 2008
Last Updated: January 15, 2016

Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
superficial tumor treatment
superficial tumors

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms processed this record on September 21, 2017