Recruiting
Phase 2

Ultra Low Dose Radiation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03398161

Conditions

Localized Skin Lesion

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

Study Details

Brief 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.

Conditions

Localized Skin Lesion

Mycosis Fungoides

Study ID

NCT03398161

Start date

Jan 6, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (ultra low dose radiation therapy)

Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.

Interventions

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Radiation Therapy

Undergo ultra low dose radiation therapy

Primary outcome measure

  • Local cutaneous control [ Time Frame: At 12 (+/-2) weeks after initial treatment ]

Central Contacts and Locations

Central contacts

Bouthaina Dabaja, MD

713-563-2300bdabaja@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Bouthaina S. Dabaja

713-563-2300

Principal Investigator:

Bouthaina S. Dabaja

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.