EUCTR2007-006064-30-GB进行中（未招募）不适用
A randomised phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma - RATH
niversity College London0 个研究点目标入组 1,200 人开始时间: 2008年2月8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
- 1,200
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
- •1. Histologically confirmed classical Hodgkin lymphoma according to the current WHO Classification. All histology will be reviewed centrally.
- •2. Stage IIB, III or IV, or stage IIA with adverse features, defined as:
- •- bulk mediastinal disease, defined as maximal diameter of mass >0.33 of the internal thoracic diameter at D5/6 on PA chest X-ray, or outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
- •- >=2 extranodal sites of disease
- •- other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
- •3. No previous treatment for Hodgkin Lymphoma
- •4. Adequate performance status (WHO 0-3); bone marrow function; renal and liver function.
- •5. Patients with a significant history of ischaemic heart disease or hypertension must have a left ventricular ejection fraction (LVEF) greater than or equal to 50%.
- •6. Written, informed consent.
- •Are the trial subjects under 18? no
- •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 1100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Poorly-controlled diabetes mellitus, or other serious medical conditions
- •2. Current pregnancy or lactation
- •3. Central nervous system or meningeal involvement by the lymphoma. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy).
- •4. Significant lung disease with abnormal lung function tests (DLCO >25% below predicted) not attributable to lymphoma
- •5. Known serology for HIV, Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors).
研究者
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