Optimal Application Dose of Superficial Hyperthermia

Universitätsmedizin Mannheim

Status and phase: Completed; Phase 3

Conditions: Tumors

Treatments: Other: Hyperthermal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00766233

MA HT-PR 01

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

1

Active Comparator group

Description:

Hyperthermal treatment once per week

Treatment:

Other: Hyperthermal treatment

2

Active Comparator group

Description:

Hyperthermal treatment 3 times a week

Treatment:

Other: Hyperthermal treatment