IRCT2017040332913N2招募中2 期
Response Evaluation of Muscle-Invasive Bladder Cancer treated With Concomitant Chemoradiation By Either Irradiation Plus Weekly Cisplatin Or Irradiation Plus Low Dose Gemcitabine By Conventional Fractionated Radiotherapy
Vice-Chancellor for Research of Iran University of Medical Sciences0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Primary carcinoma of the bladder (Transitional Cell Cancer) with
- •muscularis propria invasion diagnosed within 8 weeks of registration; clinical stage T2-T4a, Nx or N0, M0 without hydronephrosis; the patient can tolerate systemic chemotherapy combined with pelvic radiotherapy and a radical cystectomy by joint agreement of the Urologist and Oncologist; The following laboratory tests that has been done within 4 weeks prior to registration on this study is as following: WBC greater than or equal to 4000, ANC greater than or equal to 1800, Hemoglobin greater than or equal to 10.0, Platelets greater than or equal to 100,000, Creatinine clearance greater than or equal to 60ml/min, Serum creatinine of 1.5 or less, If no, the creatinine clearance is greater than 60 ml/min and serum creatinine is no more than 1.8 Serum bilirubin of less than or equal to 2.0 mg%; No evidence of distant metastases, The patient has not received prior pelvic radiation therapy or chemotherapy, nor had cancers other than non-melanoma skin cancer and early stage cancer of prostate or cervix; the patient has none of any of the severe, active co-morbidities defined as following: Unstable angina and/or congestive heart failure, requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or
- •fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; acquired immune deficiency syndrome (AIDS) based upon current CDC definition; The patient has no known severe sensitivity reactions to the drugs used in the trial.
排除标准
- 未提供
研究者
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