This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.
PRIMARY OBJECTIVES: I. To evaluate the efficacy of low dose radiation in the management of cutaneous mycosis fungoides (MF), measured as any local control for each lesion at 12 (+/- 2) weeks after the treatment, in patients with stage IA - IVB cutaneous MF. SECONDARY OBJECTIVES: I. To evaluate complete response (CR) rates at 12 (+2) weeks and beyond. II. To evaluate the persistence of response (CR, partial response \[PR\], stable disease, or progressive disease) in the treated lesion beyond 12 (+2) weeks. III. To evaluate overall survival. IV. To evaluate progression free survival. V. To evaluate patient symptom relief. VI. To evaluate the toxicity of radiation to the skin. VII. To assess if number of previous therapies including chemotherapy, targeted therapy, topical therapy, or total skin radiation affects the response. VIII. To characterize the microbiome of mycosis fungoides patient within both the lesion and unaffected skin. IX. To characterize shifts in the microbiome that occur after radiation therapy. OUTLINE: Patients undergo ultra low dose radiation therapy at the discretion of the treating physician. After completion of study treatment, patients are followed up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Ancillary studies
Ancillary studies
Undergo ultra low dose radiation therapy
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGLocal cutaneous control
Defined as local control of the treated lesion within the radiation treatment field, which will be categorized as either complete response or partial response of the lesion within the radiation treatment field. The control rate will be estimated along with 95% confidence intervals. The association between control rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. For each patient, the number of lesions under control will be summarized individually. Since there may be multiple lesions per patient, a generalized linear mixed model will be utilized to assess the clinical factor effect (e.g. previous therapies) on control rate after considering the dependence among the lesions within each patient.
Time frame: At 12 (+/-2) weeks after initial treatment
Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)
Will be described with frequency tables.
Time frame: Up to 2 years
Overall survival
Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.
Time frame: From initiation of treatment until death, assessed up to 2 years
Progression free survival
Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.
Time frame: From treatment until progression or death, assessed up to 2 years
Frequency/severity of skin toxicity
Defined by patient reported symptom surveys. Toxicity type (acute or chronic), severity and attribution will be summarized for each patient using frequency tables. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.
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Time frame: Up to 14 weeks
Microbiome analysis
Will be described with frequency tables.
Time frame: Up to 2 years
Quality of life
Will be assessed by the Skindex-16 survey. Will be summarized by domains. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.
Time frame: Up to 2 years