Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Treatment unavailable at facility
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Refractory Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Stage III Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Stage II Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Stage I Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Objective Grading of Skin Findings | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Objective Grading of Skin Findings
Primary outcomes (1)
- measure
- Change in skin-related quality of life assessed by Skindex-29
- timeFrame
- Baseline to up to 3 years
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTNewman 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 33333150