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

This study has been terminated.
(The study was discontinued after the first 10 patients because of discouraging results.)
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00496743
First received: July 2, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention
Mycosis Fungoides
 Device: Low-dose total skin electron beam therapy (4 Gy)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Response rates
  • Duration of responses

Enrollment: 10
Study Start Date: January 2002
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496743

Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Robert Gniadecki, MD Bispebjerg Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00496743     History of Changes
Other Study ID Numbers: 01-235/01
Study First Received: July 2, 2007
Last Updated: July 2, 2007
Health Authority: Denmark: Ethics Commitee of Copenhagen Municipality

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013