ISRCTN64153246已完成2 期
Phase II study of radiotherapy with concurrent weekly gemcitabine in muscle-invasive bladder cancer
Christie Hospital NHS Foundation Trust (UK)0 个研究点目标入组 50 人开始时间: 2010年7月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21205754
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histologically confirmed T2-3 N0M0 transitional cell carcinoma (TCC) of the bladder*
- •2. Life expectancy greater than 3 months
- •3. World Health Organization (WHO) performance status 0 ? 2
- •4. Patients opting for bladder preservation who are able and motivated to comply with follow up
- •5. Maximal achievable transurethral resection of bladder tumour (TURBT)
- •6. Serum creatinine less than 1.5 x upper limit of normal (ULN)
- •7. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000/mm^3, white cell count (WCC) greater than 2000/mm^3
- •8. Aged greater than 18 years
- •9. Provided informed consent
- •*Patients with TCC in whom biopsy fails to demonstrate histological evidence of muscle invasion but where magnetic resonance (MR) demonstrates unequivocal evidence of deep muscle invasion can be accepted for trial entry
排除标准
- •1. Residual tumour with any unidimensional measurement greater than or equal to 7 cm following TURBT
- •2. Poor bladder function:
- •2.1. Any WHO bladder symptom score equalling 3 or greater than or equal to two bladder symptom scores equalling 2
- •2.2. Documented bladder capacity less than or equal to 200 ml
- •3. Abnormal liver function tests (LFT) (bilirubin greater than 1.3 x ULN, alkaline phosphatase greater than 5 x ULN, transaminases greater than 5 x ULN)
- •4. Previous radiotherapy to pelvis
- •5. More than one instillation of intravesical cytotoxic chemotherapy or immunotherapy
- •6. Any previous systemic chemotherapy
- •7. Radiotherapy planning target volume (PTV) greater than 1000cm^3
- •8. Any prior malignancy (excluding basal cell carcinoma [BCC])
- •9. Pre-existing medical conditions that preclude this treatment
- •10. Pregnant or breast-feeding
- •11. Not able to use appropriate and/or adequate contraception during and for 3 months after the study
研究者
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