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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00496743
Other study ID # 01-235/01
Secondary ID
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
Est. primary completion date
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


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
See also
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Completed NCT02296164 - Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
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