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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Serious medical condition that would make treatment unsafe

Pregnant or lactating patient

Trial population

The high volume of cutaneous lymphoma patients seen at Vanderbilt makes it likely to significantly contribute to the knowledge about this treatment technique. Given the rarity of this disease, with Vanderbilt being a major treatment center for mycosis fungoides, the goal is to systematically contribute to the data for low-dose total skin electron therapy in order to prospectively assess these endpoints. It is expected to find skin manifestations of mycosis fungoides that are refractory or have relapsed on at least one prior therapy. Patients with prior skin electron therapy, including either high or low-dose total skin electron therapy, are permitted on this protocol if the radiation oncologist determines that low-dose radiation therapy can safely carried out. The goal is to assess quality of life and accurately grade skin findings following this non-experimental, standard of care, total skin electron radiation treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality-of-Life Assessment

    Other intervention

    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.

  • Objective Grading of Skin Findings

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Quality of Life/ Grading Skin Findings2 interventions

Trial outcomes

Primary outcomes

1

Change in skin-related quality of life assessed by Skindex-29

Skindex-29 is a validated quality of life questionnaire to help quantify how mycosis fungoides may affect one's quality of life on a day to day basis, including emotional impact of the skin disease.

Time frame
Baseline to up to 3 years

Secondary outcomes

1

Change in the durability of response assessed by mSWAT tool

mSWAT is the Modified Severity Weighted Assessment Tool used by the radiation oncologist during complete physical examination to quantify skin findings of patches, plaques, and tumors in all regions of the body; this would help the radiation oncologist and dermatologist to better follow the response to treatment.

Time frame
Baseline to up to 3 years
2

Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique

The patient will be closely monitored by the radiation oncologist during treatment, with at least 2-3 visits while patient is on treatment. Side effects will be documents in patient medical records.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator