ISRCTN84356042已完成2 期
MRC BA08 trial: A phase II trial of cisplatin, methotrexate and vinblastine (CMV) chemotherapy for pure squamous cell cancer of the urinary tract
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30650143 results (added 22/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Pure squamous cell carcinoma of the urinary tract in one of the following groups:
- •1.1. initial presentation with T3-T4 disease
- •1.2. pelvic relapse after radiotherapy or surgery
- •1.3. nodal or metastatic disease
- •2. At least one site of disease assessable for response by clinical examination or imaging. One or more of the sites below can be used to assess response:
- •2.1. primary bladder tumour (satisfactory measurements of the primary tumour if present and measureable, must have been made by bimanual examination after transurethral resection (TUR))
- •2.2. other primary tumours in the urinary tract (satisfactory measurements of the primary tumour in the urinary tract, if present and measureable, must have been made by clinical examination or appropriate imaging)
- •2.3. pelvic relapse after radiotherapy or surgery (at least one indicator lesion must be measurable by clinical examination or appropriate imaging)
- •2.4. nodal or metastatic disease (at least one indicator lesion must be measurable by clinical examination or appropriate imaging. NB: Bone metastases cannot be used as an indicator lesion.
- •3. Calculated glomerular filtration rate (GFR), calculated by the method of Cockcroft and Gault (1976) >50 ml/min. In patients with impaired renal function secondary to ureteric obstruction this may be relieved by ureteric stents or nephrostomies, and if the renal function then recovers the patient will be eligible.
- •4. White blood cell count >3.5 x 10(9)/l and platelet count >100 x 10(9)/l
- •5. No previous systemic treatment with chemotherapy
- •6. No concomitant or previous malignancy other than basal cell carcinoma of skin or carcinoma in-situ of the cervix
- •7. Fit to tolerate CMV
排除标准
- •1. Transitional cell carcinoma with squamous metaplasia, or other mixed tumours
- •2. Co-existing illness (e.g. cardiac failure) that may compromise administration of CMV chemotherapy
研究者
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