Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides

  • STATUS
    Recruiting
  • End date
    Jun 13, 2026
  • participants needed
    60
  • sponsor
    Vanderbilt-Ingram Cancer Center
Updated on 23 February 2022

Summary

This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

Description

PRIMARY OBJECTIVES:

I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

II. To assess the durability of response using an established method (modified Severity-Weight Assessment [mSWAT] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique.

OUTLINE

The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21.

After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.

Details
Condition Recurrent Mycosis Fungoides, Refractory Mycosis Fungoides, Stage I Mycosis Fungoides, Stage II Mycosis Fungoides, Stage III Mycosis Fungoides
Treatment quality-of-life assessment, Objective Grading of Skin Findings
Clinical Study IdentifierNCT02702310
SponsorVanderbilt-Ingram Cancer Center
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Biopsy confirmed mycosis fungoides stage IB-IIIA
Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids
Life expectancy > 6 months

Exclusion Criteria

Serious medical condition that would make treatment unsafe
Pregnant or lactating patient
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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