Optimal Application Dose of Superficial Hyperthermia
Primary Purpose
Tumors
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Hyperthermal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Tumors focused on measuring Hyperthermia, superficial tumor treatment, superficial tumors
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
Sites / Locations
- Department of Radiotherapy University Hospital Mannheim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Hyperthermal treatment once per week
Hyperthermal treatment 3 times a week
Outcomes
Primary Outcome Measures
Complete remission (Imaging / clinical)
Secondary Outcome Measures
Progression-free survival, overall survival, Quality of life
Full Information
NCT ID
NCT00766233
First Posted
October 2, 2008
Last Updated
September 28, 2021
Sponsor
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT00766233
Brief Title
Optimal Application Dose of Superficial Hyperthermia
Official Title
Phase III Study for Analysis of the Optimal Application Dose of Superficial Hyperthermia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors
Keywords
Hyperthermia, superficial tumor treatment, superficial tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Hyperthermal treatment once per week
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hyperthermal treatment 3 times a week
Intervention Type
Other
Intervention Name(s)
Hyperthermal treatment
Intervention Description
Hyperthermal treatment one or three times per week for 60 minutes
Primary Outcome Measure Information:
Title
Complete remission (Imaging / clinical)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression-free survival, overall survival, Quality of life
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Radiotherapy University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
12. IPD Sharing Statement
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Optimal Application Dose of Superficial Hyperthermia
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