Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides (NCT03398161) | Clinical Trial Compass
RecruitingPhase 2
Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
United States50 participantsStarted 2018-01-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Local cutaneous control
Timeframe: At 12 (+/-2) weeks after initial treatment