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Ultra Low Dose Radiation Therapy for Mycosis Fungoides

This study is testing a treatment called ultra low dose radiation therapy for patients with mycosis fungoides (a type of skin lymphoma). Radiation therapy uses high-energy X-rays to target and shrink tumors. Researchers want to see if using a very low dose of radiation can control the disease effectively while causing fewer side effects compared to higher doses. The study is open to adults aged 18 and older who have mycosis fungoides with at least one measurable skin lesion. The main goal is to see how well the radiation therapy controls the treated lesions after about 12 weeks. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a treatment. It aims to enroll 50 participants.
What's involved
You would undergo ultra low dose radiation therapy. After treatment, you would have follow-up visits at specific intervals for up to two years.
Compensation
Not stated in the trial record.
Follow-up
You would be 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 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03398161

Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire AdministrationRadiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local cutaneous control
Measured over At 12 (+/-2) weeks after initial treatment

Conditions

Localized Skin Lesion
Mycosis Fungoides

Explore related trials

Mycosis Fungoides

NCT03398161

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bouthaina S Dabaja · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Bouthaina Dabaja, MD
[email protected]
713-563-2300
Email the study team

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Eligibility criteria

Inclusion

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 skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.
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.
Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
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.
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.

What this trial measures

  • Local cutaneous controlAt 12 (+/-2) weeks after initial treatment

    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.