ACTRN12610000927022已完成3 期
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
niversity College0 个研究点目标入组 1,203 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,203
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically confirmed classical Hodgkin lymphoma (HL) according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted). All histology will be reviewed by a central pathology panel for the group concerned
- •2. Aged 18 or above
- •3. Clinical stage IIB, IIIA, IIIB or IV, or Clinical stage IIA with adverse features:
- •-bulk mediastinal disease, defined as maximal transverse diameter of mass >0.33 of the internal thoracic diameter at D5/6 interspace on routine chest X-ray
- •-outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
- •-more than two sites of disease
- •-other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
- •4. No previous chemotherapy, radiotherapy or other investigational drug for HL
- •5. Performance status 0-3
- •6. Adequate bone marrow function with platelets > 100x10e9/l; neutrophils > 1.5x10e9/l at the time of study entry unless lower numbers are attributed to bone marrow infiltration by lymphoma
- •7. Serum creatinine less than 150% of the upper limit of normal, serum bilirubin less than twice the upper limit of normal and transaminases < 2.5× upper limit of normal unless attributed to lymphoma
- •8. Patients with a significant history of ischaemic heart disease or hypertension must have an acceptable left ventricular ejection fraction (LVEF) =50%
- •9. Life expectancy > 3 months
- •10. All patients of childbearing potential are willing to use adequate contraceptive precautions
- •11. Written, informed consent
- •12. Access to PET-CT scanning
排除标准
- •1. Poorly controlled Diabetes mellitus
- •2. Other concurrent uncontrolled medical condition
- •3. Pregnant or lactating
- •4. Known central nervous system or meningeal involvement by the lymphoma
- •5. Cardiac contra-indication to doxorubicin: abnormal contractility on echocardiography or nuclear medicine examination (MUGA)
- •6. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy)
- •7. General status that does not allow the administration of a full course of chemotherapy according to the investigator
- •8. Previous history of active malignant disease other than fully excised basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years
- •9. Known positive serology for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors)
- •10. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
研究者
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