Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Sponsor
Bispebjerg Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00496743
Collaborator
(none)
10
48
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Study Start Date
:
Jan 1, 2002
Actual Study Completion Date
:
Jan 1, 2006
Outcome Measures
Primary Outcome Measures
- Response rates []
- Duration of responses []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bispebjerg Hospital
Investigators
- Principal Investigator: Robert Gniadecki, MD, Bispebjerg Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00496743
Other Study ID Numbers:
- 01-235/01
First Posted:
Jul 4, 2007
Last Update Posted:
Jul 4, 2007
Last Verified:
Jul 1, 2007