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
Not Provided
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycosis Fungoides
Device: Low-dose total skin electron beam therapy (4 Gy)
Not Provided
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00496743
01-235/01
No
Not Provided
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