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

NCT02702310 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Quality-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.

OTHER

Objective 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Austin Kirschner, MD, PhD · Vanderbilt-Ingram Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-22
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02702310 on ClinicalTrials.gov