A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
18 Years
N/A
Both
Mycosis Fungoides
Trial Information
A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Current treatment modalities are usually not curative and having treatment options suitable
for the long-term control therefore essential. Electron beam therapy is generally applied to
the skin in total doses of 30-36 Gy over a 8-10 week period.Due to the potential risk of
toxicity including bone marrow supression, no more than 2-3 courses in a life time are
generally recommended. In the current study we explored the possibility of using lower
radiation doses for total skin electron beam therapy for long-term disease control.
Inclusion Criteria:
- histologically confirmed mycosis fungoides stage I-II with failure to obtain full
remission after standard PUVA treatment or relapse within 4 months of PUVA treatment
Exclusion Criteria:
- under 18 years, pregnancy, other somatic diseases with a life expentancy under 1/2
years, psycological disorder preventing the patient to understand the information and
cooperate in the treatment
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rates
Principal Investigator
Robert Gniadecki, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Bispebjerg Hospital
Authority:
Denmark: Ethics Commitee of Copenhagen Municipality
Study ID:
01-235/01
NCT ID:
NCT00496743
Start Date:
January 2002
Completion Date:
January 2006
Related Keywords:
- Mycosis Fungoides
- Mycoses
- Mycosis Fungoides
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