RecruitingNCT02702310

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

Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique

Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

60 participants

Start Date

May 22, 2016

Study Type

OBSERVATIONAL

Conditions

Recurrent Mycosis Fungoides Refractory Mycosis Fungoides Stage I Mycosis Fungoides Stage II Mycosis Fungoides Stage III Mycosis Fungoides

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a low-dose version of total skin electron therapy (TSET) — a special type of radiation that treats the entire surface of the skin — in patients with mycosis fungoides, a slow-growing type of skin lymphoma (cancer of the immune cells in the skin), to see if a lower dose is effective with fewer side effects. **You may be eligible if...** - You have been diagnosed with mycosis fungoides (a type of skin lymphoma) - Your disease involves widespread areas of skin that could benefit from radiation to the whole skin surface - You are in adequate health to receive radiation treatment - You have not received full-dose total skin electron therapy previously, or it has been a sufficient time since last treatment **You may NOT be eligible if...** - You have a form of skin lymphoma other than mycosis fungoides - You have already received too much radiation to safely receive more - You have a serious infection of the skin at the time of treatment - You are pregnant - Your disease is confined to one small area of skin (localized) that could be treated with targeted radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQuality-of-Life Assessment

At initial visit (day 1) - for determination of a baseline quality of life, patients will be given a self-reported questionnaire called the Skindex-29. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, patients will complete the Skindex-29 questionnaire.

OTHERObjective Grading of Skin Findings

At initial visit (day 1) , using mSWAT the radiation oncologist can follow the patient's treatment response by accurately grading the severity of the patient's skin findings. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, mSWAT will again be determined by physician. Follow-up visits will continue until patient has a change in disease.

Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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NCT02702310

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