Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Local cutaneous control
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
I. 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:
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment (ultra low dose radiation therapy)
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
干预措施: Questionnaire Administration (Other)
Treatment (ultra low dose radiation therapy)
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
干预措施: Radiation Therapy (Radiation)
Treatment (ultra low dose radiation therapy)
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Local cutaneous control
时间窗: At 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.
次要结局
- Overall survival(From initiation of treatment until death, assessed up to 2 years)
- Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)(Up to 2 years)
- Progression free survival(From treatment until progression or death, assessed up to 2 years)
- Quality of life(Up to 2 years)
- Frequency/severity of skin toxicity(Up to 14 weeks)
- Microbiome analysis(Up to 2 years)