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临床试验/EUCTR2005-002765-37-DK
EUCTR2005-002765-37-DK进行中(未招募)不适用

The H10 EORTC/GELA randomized Intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma. - H10

Euopean Organisation of Research and Treatment of Cancer0 个研究点目标入组 1,600 人开始时间: 2006年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,600

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Histologically proven Hodgkin’s lymphoma, except for the nodular lymphocyte predominant subtype (nodular paragranuloma)
  • - Supradiaphragmatic Ann Arbor clinical stage I or II, both favorable and unfavorable
  • prognostic subsets (for definition of favorable (F) and unfavorable (U), see at the end of this section)
  • - Previously untreated
  • - Age 15 through 70 years
  • - FDG-PET scan already prospectively planned after two cycles of ABVD for all patients
  • (see Appendix G).
  • - WHO performance status grades 0, 1, 2 or 3 (see Appendix B) during the whole duration of study treatment.
  • - Absence of severe cardiac, pulmonary, neurologic psychiatric or metabolic disease. Patients with unstable diabetes mellitus are excluded (to avoid uninterpretable FDG-PET scan).
  • - Adequate liver and renal function (total serum bilirubin = 2.5 x ULN, serum creatinine = 2.5 x ULN)
  • - No concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years
  • - No known HIV infection
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 未提供

研究者

发起方
Euopean Organisation of Research and Treatment of Cancer

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NL-OMON29848European Organisation for Research in Treatment of Cancer (EORTC)500