Optimal Application Dose of Superficial Hyperthermia

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766233
• Other study ID #: MA HT-PR 01
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: February 2016

Study information

• Verified date: September 2021
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Tumors

Intervention

Other:
• Hyperthermal treatment
Hyperthermal treatment one or three times per week for 60 minutes

Locations

Country	Name	City	State
Germany	Department of Radiotherapy University Hospital Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission (Imaging / clinical)		5 years
Secondary	Progression-free survival, overall survival, Quality of life		5 years