NCT03398161

Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Localized Skin Lesion
• Mycosis Fungoides

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo ultra low dose radiation therapy

Timeline

• Start date: 2018-01-06
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2018-01-12
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States