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

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Recurrent Mycosis Fungoides; Refractory Mycosis Fungoides; Stage III Mycosis Fungoides; Stage I Mycosis Fungoides; Stage II Mycosis Fungoides

Treatments: Other: Quality-of-Life Assessment; Other: Objective Grading of Skin Findings

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02702310

NCI-2015-02293 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

VICC RAD 1633

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Quality of Life/ Grading Skin Findings

Description:

Patients' baseline quality of life is established by completion of an initial questionnaire, and skin lesion burden is quantified by physical examination using a recommended system . Following the standard of care radiation therapy, patients' completion of questionnaire, and physical examination is repeated for continued assessment.

Treatment:

Other: Objective Grading of Skin Findings

Other: Quality-of-Life Assessment