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NCT Number: NCT00766233

Optimal Application Dose of Superficial Hyperthermia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Radiotherapy University Hospital Mannheim

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermal treatment

Other

Hyperthermal treatment one or three times per week for 60 minutes

Primary outcomes

  1. Complete remission (Imaging / clinical)

    Time frame: 5 years

Secondary outcomes

  1. Progression-free survival, overall survival, Quality of life

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2008
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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