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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Mycosis Fungoides

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Robert Gniadecki, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Other Identifiers

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01-235/01

Identifier Type: -

Identifier Source: org_study_id