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Optimal Application Dose of Superficial Hyperthermia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766233
First Posted: October 3, 2008
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766233


Locations
Germany
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
ClinicalTrials.gov Identifier: NCT00766233     History of Changes
Other Study ID Numbers: MA HT-PR 01
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: January 18, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms