Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Local Progression-Free Interval in Irradiated Field
研究概览
简要总结
Primary indolent cutaneous B cell lymphomas (PCBCL) are rare: although data on outcomes and treatment are limited, traditionally they have been treated with radiation doses in excess of 24 Gy. Recently, some trials that patients with primary cutaneous indolent lymphoma managed with very low dose (4 Gy) RT (LDRT) have shown that high response rates and durable remission can be achieved; unfortunately, given the retrospective nature of these studies, the role of LDRT in indolent PMCL remains undefined. The objective of this retrospective multicentric trial is to investigate the efficacy of low-dose involved-field radiation therapy in patients with primary indolent cutaneous B-cell Lymphoma.
详细描述
Primary cutaneous B-cell lymphomas (PCBCL) represent approximately 20% of all primary cutaneous lymphoma and are defined by a restricted disease spread to the skin without evidence of extracutaneous involvement at diagnosis. They encompass three main types: primary cutaneous marginal zone lymphoma (PCMZL), primary cutaneous follicle center lymphoma (PCFCL) and primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), of which the first two entities are indolent. Radiotherapy (RT) is part of the therapeutic mosaic for PCBCL and recommended by both national and international guidelines for a localized disease pattern, conferring high local control rates with a conservative approach . Curative doses cover a range of 18-54 Gy and complete remission is common regardless of which treatment is used. There is accumulating evidence for a possible de-escalation of RT dose while maintaining high response rates and thereby opening a role for low-dose RT (LDRT), which has been successfully shown for other indolent non-Hodgkin lymphoma. However, the rarity of indolent PCBCL and retrospective nature of studies make a definitive dose recommendation troublesome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age greater than or equal to 18 years
- •Histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS)
- •Primary cutaneous location
- •Early stage (I-II)
- •First diagnosis or recurrence
- •Low-dose radiotherapy treatment (4 Gy/2 sessions)
排除标准
- •Aggressive histology lymphomas
- •Advanced stages
- •Extracutaneous localisation
- •Radiotherapy dose administered > 4 Gy
- •Patients without histological typing
- •Patients without follow-up
结局指标
主要结局
Local Progression-Free Interval in Irradiated Field
时间窗: 12 months
Time from the start of low dose radiotherapy (LDRT) to tumor progression within the irradiated field
次要结局
- Acute toxicity(4 weeks)
- Late toxicity(12 weeks)
- Tumor response in irradated area(12 weeks)
- Overall survival (OS)(24 months)
- Overall response rate (ORR)(12 weeks)
- Progression-Free Survival (PFS)(24 months)