Optimal Application Dose of Surface Hyperthermia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universitätsmedizin Mannheim.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT00766233
First received: October 2, 2008
Last updated: February 9, 2011
Last verified: February 2011
  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 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.


Condition Intervention Phase
Tumors
Other: Hyperthermal treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study for Analysis of the Optimal Application Dose of Surface Hyperthermia

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Complete remission (Imaging / clinical) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, overall survival, Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • CEM 42°C T75

Exclusion Criteria:

  • Pregnancy
  • Pace maker
  • Metal implants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766233

Locations
Germany
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Wenz, Prof. Dr. med.    00496213834960    frederik.wenz@medma.uni-heidelberg.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Prof. Dr. med F. Wenz, Department of Radiotherapy
ClinicalTrials.gov Identifier: NCT00766233     History of Changes
Other Study ID Numbers: MA HT-PR 01
Study First Received: October 2, 2008
Last Updated: February 9, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
Hyperthermia
superficial tumor treatment
superficial tumors

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

ClinicalTrials.gov processed this record on August 28, 2014