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Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides

This study has been terminated.
(The study was discontinued after the first 10 patients because of discouraging results.)
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00496743
First received: July 2, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 2, 2007
July 2, 2007
January 2002
Not Provided
  • Response rates
  • Duration of responses
Same as current
No Changes Posted
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Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of stage IB-II 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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycosis Fungoides
Device: Low-dose total skin electron beam therapy (4 Gy)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00496743
01-235/01
No
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Bispebjerg Hospital
Not Provided
Principal Investigator: Robert Gniadecki, MD Bispebjerg Hospital
Bispebjerg Hospital
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP