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

Mycosis Fungoides Clinical Trial

Official title:

A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00496743
• Other study ID #: 01-235/01
• Status: Terminated
• Phase: N/A
• First received: July 2, 2007
• Last updated: July 2, 2007
• Start date: January 2002
• Est. completion date: January 2006

Study information

• Verified date: July 2007
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Commitee of Copenhagen Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Device:
• Low-dose total skin electron beam therapy (4 Gy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates
Primary	Duration of responses