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临床试验/NCT02867553
NCT02867553Unknown3 期

Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions

CHU de Reims1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
CHU de Reims
入组人数
36
试验地点
1
主要终点
Disease free survival

研究概览

简要总结

Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The radiotherapy is currently the most widely used treatment, with complete response rate close to 100% for a lesion treated. However, it has limits when there are outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in three), or during recurrences. In these situations, conventional chemotherapy is not recommended and multi-field radiotherapy is often used empirically, but its effectiveness has never been studied prospectively.

Recently, retrospective studies with small numbers patients (totaling sixty patients) reported complete response rates of 80 to 100% with rituximab (anti-cluster of differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized treatment by intravenous with a recurrence rate of less than one case in three. These data suggest that rituximab by intravenous with a standardized initial cycle followed by a maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with multiple lesions or of recurrent lesions.

详细描述

Compare the efficacy and safety of two treatment strategies for indolent cutaneous B cell lymphomas with multiple or recurrent lesions: Rituximab by intravenous versus multi-field radiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • patients with histological diagnosis of indolent cutaneous B cell lymphomas
  • patients with multiple lesions inaccessible to a single field of radiotherapy or patients with a recurrence outside the field of first radiotherapy
  • patient with a lesion of at least 15 mm in major axis and a total tumor surface area greater or egal than 4 cm2
  • patient with a negative staging
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

排除标准

  • contraindication for rituximab or radiotherapy
  • immunosuppressive therapy
  • immunosuppression

研究组 & 干预措施

Rituximab by intravenous

Experimental

attack treatment (4 slow intravenous perfusions of rituximab at a dose of 375 mg / m2 on day 1, day 8, day 15 and day 22) and maintenance treatment (intravenous perfusions of rituximab at a dose of 375 mg / m2 every 2 months for 2 years).

干预措施: rituximab (Drug)

multi-field radiotherapy

Active Comparator

multi-fields radiotherapy with a dose between 20 and 30 gray and a fractionated dose over 2 at 3 weeks.

干预措施: Multi-fields radiotherapy (Radiation)

结局指标

主要结局

Disease free survival

时间窗: 5 years

Disease free survival

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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