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New treatment option for Localized Skin Lesion
Official title Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
ClinicalTrials.gov ID: NCT03398161
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly...
You likely can't join if
- 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...
- Patients with active lupus or scleroderma
- Lesions with a height \> 1 cm measured from the skin surface are not eligible for this protocol.
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.