Optimal Application Dose of Superficial Hyperthermia

NCT00766233 | Completed Phase 3

• 1 other identifier: MA HT-PR 01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Hyperthermia; superficial tumor treatment; superficial tumors

Outcome Measures

Primary Outcomes (1)

• Complete remission (Imaging / clinical)

  5 years

Secondary Outcomes (1)

• Progression-free survival, overall survival, Quality of life

  5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Hyperthermal treatment once per week

Other: Hyperthermal treatment

2

ACTIVE COMPARATOR

Hyperthermal treatment 3 times a week

Other: Hyperthermal treatment

Interventions

Hyperthermal treatment OTHER

Hyperthermal treatment one or three times per week for 60 minutes

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Pace maker
• Metal implants

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Department of Radiotherapy University Hospital Mannheim

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Neoplasms; Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Wenz

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

DE (1)