ISRCTN99811594已完成3 期
A randomised phase III trial to determine the role of FluoroDeoxyGlucose-Positron Emission Tomography imaging in clinical stages Ia/IIa Hodgkin's disease
eukaemia Research Fund (UK)0 个研究点目标入组 571 人开始时间: 2003年10月21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
- 571
研究概览
简要总结
2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25901426 results (added 14/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 16 - 75 years, either sex
- •2. Histologically confirmed Hodgkin's disease (histology will be reviewed retrospectively by Professor A Jack at the Haematological Malignancy Diagnostic Service in Leeds but please note that this is not required before trial entry)
- •3. Clinical stages Ia/IIa above the diaphragm with no mediastinal bulk (defined as maximum transverse diameter of mediastinal mass: internal thoracic diameter at level of D5/6 interspace greater than 0.33). Bulky disease at other sites (defined as nodal mass with transverse diameter greater than 10 cm) is acceptable.
- •4. No previous treatment for Hodgkin's disease
- •5. No previous malignancy excepting appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •6. No contraindications to chemotherapy or radiotherapy
- •7. Patients with reproductive potential: a willingness to use contraception from entry into the study for a period of 6 months
- •8. Written informed consent
排除标准
- •1. Patients with clinical stage Ia Hodgkin's disease with no clinical or computed tomography (CT) evidence of disease after diagnostic biopsy
- •2. Pregnant or lactating women
- •3. Severe underlying illness considered likely to make the trial therapy hazardous (for example severe heart disease or lung fibrosis)
- •4. Patients unwilling to travel to the nearest PET Centre
- •5. Patients unable to comply with follow-up arrangements
研究者
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