Overview

This trial is active, not recruiting.

Condition tumors
Treatment hyperthermal treatment
Phase phase 3
Sponsor Universitätsmedizin Mannheim
Start date January 2008
End date January 2016
Trial size 17 participants
Trial identifier NCT00766233, MA HT-PR 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Hyperthermal treatment once per week
hyperthermal treatment
Hyperthermal treatment one or three times per week for 60 minutes
(Active Comparator)
Hyperthermal treatment 3 times a week
hyperthermal treatment
Hyperthermal treatment one or three times per week for 60 minutes

Primary Outcomes

Measure
Complete remission (Imaging / clinical)
time frame: 5 years

Secondary Outcomes

Measure
Progression-free survival, overall survival, Quality of life
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase III Study for Analysis of the Optimal Application Dose of Superficial Hyperthermia
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Universitätsmedizin Mannheim.