Optimal Application Dose of Superficial Hyperthermia

Phase 3

Completed

• Conditions: Tumors
• Interventions: Other: Hyperthermal treatment

• Registration Number: NCT00766233
• Lead Sponsor: Universitätsmedizin Mannheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hyperthermal treatment	Hyperthermal treatment once per week
2	Hyperthermal treatment	Hyperthermal treatment 3 times a week

Primary Outcome Measures

Name	Time	Method
Complete remission (Imaging / clinical)	5 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, overall survival, Quality of life	5 years

Trial Locations

Locations (1)

Department of Radiotherapy University Hospital Mannheim; 🇩🇪 Mannheim, Germany