Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2018 |
| Start Date: | April 2016 |
| End Date: | March 2021 |
| Contact: | VICC Clinical Trials Information Program |
| Phone: | 800-811-8480 |
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
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.
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.
PRIMARY OBJECTIVES:
I. To assess the skin-related quality of life using an established method (Skindex-29), with
comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.
II. To assess the durability of response using an established method (modified
Severity-Weight Assessment [mSWAT] tool), with comparisons made between pre-treatment and
each of follow-up post-treatment skin assessments.
III. To determine side effect profile for low dose total skin electron therapy (TSE) for
mycosis fungoides administered via rotisserie technique.
OUTLINE:
The investigational portion of this research study involves collecting quality of life (QOL)
questionnaire data and objective measurements of patients' skin responses, which are obtained
by the radiation oncologist during the patient's standard of care radiation treatment
planning. Patients will also undergo standard of care low-dose total skin electron therapy
for under 1 hour daily on days 10-21.
After completion of study treatment, patients are followed up at 6 and 12 weeks, and then
every 3 months thereafter.
I. To assess the skin-related quality of life using an established method (Skindex-29), with
comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.
II. To assess the durability of response using an established method (modified
Severity-Weight Assessment [mSWAT] tool), with comparisons made between pre-treatment and
each of follow-up post-treatment skin assessments.
III. To determine side effect profile for low dose total skin electron therapy (TSE) for
mycosis fungoides administered via rotisserie technique.
OUTLINE:
The investigational portion of this research study involves collecting quality of life (QOL)
questionnaire data and objective measurements of patients' skin responses, which are obtained
by the radiation oncologist during the patient's standard of care radiation treatment
planning. Patients will also undergo standard of care low-dose total skin electron therapy
for under 1 hour daily on days 10-21.
After completion of study treatment, patients are followed up at 6 and 12 weeks, and then
every 3 months thereafter.
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
We found this trial at
1
site
2220 Pierce Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Chirayu Patel
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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