Back to resultsStudy of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Primary Purpose
Mycosis Fungoides
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-dose total skin electron beam therapy (4 Gy)
Sponsored by
About this trial
This is an interventional treatment trial for Mycosis Fungoides
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Response rates
Duration of responses
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00496743
Brief Title
Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Official Title
A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued after the first 10 patients because of discouraging results.
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Low-dose total skin electron beam therapy (4 Gy)
Primary Outcome Measure Information:
Title
Response rates
Title
Duration of responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gniadecki, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
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