Localized Skin LesionPhase 2NCT03398161

Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

A Phase 2 study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy in people with Localized Skin Lesion and Mycosis Fungoides, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Localized Skin Lesion, Mycosis Fungoides
What is being tested?: Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2018to 31 Dec 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

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
Being tested: Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy
Medical subject headings: Mycosis Fungoides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Undergo ultra low dose radiation therapy

Study groups in NCT03398161
Study group	Role	What they receive
Treatment (ultra low dose radiation therapy)	Experimental	Patients undergo ultra low dose radiation therapy at the discretion of the treating physician. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Local 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.
Measured: At 12 (+/-2) weeks after initial treatment

Secondary outcomes (6)

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.
Measured: Up to 2 years
Overall survival
Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.
Measured: 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.
Measured: 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.
Measured: Up to 14 weeks
Microbiome analysis
Will be described with frequency tables.
Measured: 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.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 201831 Dec 2027

First posted12 Jan 2018
Study start6 Jan 2018
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Localized Skin LesionStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03398161
Sponsor's protocol ID: 2017-0276
Other IDs: NCI-2018-00861, 2017-0276, P30CA016672
Status last verified: Oct 2026
First submitted: 8 Jan 2018
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No