Actively Recruiting
Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ultra low dose radiation therapy as a treatment for patients with mycosis fungoides, a type of cutaneous lymphoma. This phase II trial aims to see how well this lower dose radiation controls skin lesions compared to higher doses and whether it reduces side effects. The study includes patients with all stages of the disease and explores effects on tumor control, symptom relief, survival, and skin toxicity. Participants receive ultra low dose radiation therapy at the physician's discretion targeting lesions that are 1 cm or smaller in height on the skin. Multiple lesions per patient can be treated individually. The study also includes assessments of the skin microbiome before and after radiation. Treatments are given locally, focusing on controlling each lesion. During the study, patients are followed at 4-6 weeks and 10-14 weeks after treatment, then every 3 months for 6-8 months, and finally every 6-12 months for up to 2 years. Researchers measure local lesion control at 12 weeks, along with response rates, symptom relief, skin toxicity, overall and progression-free survival, quality of life, and changes in skin microbiome. Questionnaires and quality of life assessments are also part of the study.
CONDITIONS
Brief Title
Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed mycosis fungoides affecting the skin
- Patients must have at least one measurable skin lesion on physical exam
- New lesions can be enrolled without additional biopsy if previously diagnosed
- Eligible lesions must be 1 cm or smaller in height from the skin surface
- All disease stages (IA through IVB) where radiation is considered for local control
- Patients receiving systemic therapy for advanced disease are eligible
- Female patients of childbearing potential must have a negative pregnancy test or declare not pregnant
- Topical treatments on other lesions are allowed if not applied to the enrolled lesion within 24 hours prior to enrollment
You will not qualify if you...
- Pregnant patients are excluded from radiation therapy
- Patients with active lupus or scleroderma are excluded
- Lesions taller than 1 cm from the skin surface are not eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies as per treating physician's discretion
Participants undergo ultra low dose radiation therapy to manage cutaneous mycosis fungoides.
Visits as needed for radiation therapy sessions
Duration - Up to 2 years
After treatment, participants are followed up to assess local control, symptom relief, toxicity, and overall health.
Visits at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bouthaina Dabaja, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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