Phase III Study for Analysis of the Optimal Application Dose of Surface Hyperthermia
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Tumors
Both
Tumors
Trial Information
Phase III Study for Analysis of the Optimal Application Dose of Surface Hyperthermia
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
- CEM 42°C T75
Exclusion Criteria:
- Pregnancy
- Pace maker
- Metal implants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission (Imaging / clinical)
Outcome Time Frame:
5 years
Safety Issue:
No
Authority:
Germany: Ethics Commission
Study ID:
MA HT-PR 01
NCT ID:
NCT00766233
Start Date:
January 2008
Completion Date:
December 2011
Related Keywords:
- Tumors
- Hyperthermia
- superficial tumor treatment
- superficial tumors
- Fever
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