Last updated on November 2018

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02702310

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Recruitment Status: Open


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