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
3 other identifiers
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedStudy Start
First participant enrolled
May 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 28, 2025
March 1, 2025
10.3 years
February 29, 2016
March 24, 2025
Conditions
Outcome Measures
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.
Baseline to up to 3 years
Secondary Outcomes (2)
Change in the durability of response assessed by mSWAT tool
Baseline to up to 3 years
Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique
Up to 3 years
Study Arms (1)
Quality of Life/ Grading Skin Findings
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Serious medical condition that would make treatment unsafe
- Pregnant or lactating patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Newman NB, Patel CG, Ding GX, Zic JA, Zwerner J, Osmundson EC, Kirschner AN. Prospective observational trial of low-dose skin electron beam therapy in mycosis fungoides using a rotational technique. J Am Acad Dermatol. 2021 Jul;85(1):121-127. doi: 10.1016/j.jaad.2020.12.023. Epub 2020 Dec 14.
PMID: 33333150RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin Kirschner, MD, PhD
Vanderbilt-Ingram Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 8, 2016
Study Start
May 22, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 28, 2025
Record last verified: 2025-03