Optimal Application Dose of Superficial Hyperthermia

NCT ID: NCT00766233

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2016-02-29

Brief 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.

Conditions

Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Hyperthermal treatment once per week

Group Type: ACTIVE_COMPARATOR

Hyperthermal treatment

Intervention Type: OTHER

Hyperthermal treatment one or three times per week for 60 minutes

2

Hyperthermal treatment 3 times a week

Group Type: ACTIVE_COMPARATOR

Hyperthermal treatment

Intervention Type: OTHER

Hyperthermal treatment one or three times per week for 60 minutes

Interventions

Hyperthermal treatment

Hyperthermal treatment one or three times per week for 60 minutes

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Frederik Wenz

Prof. Dr. med. Wenz

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Radiotherapy University Hospital Mannheim

Mannheim, , Germany

Countries

Germany

Other Identifiers

MA HT-PR 01

Identifier Type: -

Identifier Source: org_study_id