Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 25 May 2022
systemic therapy
serum pregnancy test
measurable disease
human chorionic gonadotropin
tumor cells
low dose radiation therapy


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.



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.


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.


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.

Condition Localized Skin Lesion, Mycosis Fungoides
Treatment radiation therapy, questionnaire administration, quality-of-life assessment, Symptom questionnaire, Photographs, Microbiome Analysis
Clinical Study IdentifierNCT03398161
SponsorM.D. Anderson Cancer Center
Last Modified on25 May 2022


Yes No Not Sure

Inclusion Criteria

Patients with pathologically confirmed MF with cutaneous involvement
Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam
If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation
Lesions of any surface span as long as =< 1 cm in maximal height measured from the
All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible
skin surface for which local control is desired are eligible; a single patient
Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible
may have multiple eligible lesions that are individually enrolled for the
Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test
Patients who are receiving or are planned to start topical chemotherapeutics, retinoids or imiquimod to other lesions that are not planned for enrollment are eligible; however, the lesion being considered for enrollment should not be under active therapy with these topical agents immediately prior to enrollment
Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate for enrollment must be halted at least 24 hours prior to enrollment in the study

Exclusion Criteria

Pregnant patients do not meet inclusion criteria for radiation therapy
Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled
Patients with active lupus or scleroderma
Lesions with a height > 1 cm measured from the skin surface are not eligible for this protocol
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