ISRCTN29976507已完成不适用
Efficacy and toxicity of concomitant chemoradiation with weekly gemcitabine/cisplatin in comparison with weekly cisplatin in cervical cancer: a phase II, randomised trial
Shaheed Beheshti University of Medical Science (SBMU) (Iran)0 个研究点目标入组 80 人开始时间: 2007年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- 性别
- Female
入选标准
- •1. Women with untreated locally advanced cervical cancer International Federation of Gynaecology and Obstetrics (FIGO) stage IB, II, III, IVA
- •2. Histologically confirmed Squamous Cell Carcinoma (SCC)
- •3. Aged between 18 - 70 years
- •4. Performance status less than or equal to 2 in Eastern Cooperative Oncology Group (ECOG) scale
- •5. No active co-morbid illness (uncontrolled infection, cardiopulmonary disease, uncontrolled diabetes mellitus)
- •6. Laboratory data at start of chemotherapy:
- •6.1. Haemoglobin (Hb) 12 g/dl or corrected to 11 g/dl before the start of therapy
- •6.2. Platelets (Plt) 100 x 10^9/L
- •6.3. Absolute Neutrophil Count (ANC) more than or equal to 1.5 x 10^9/L
- •6.4. Creatinine (Cr) less than or equal to 1.5 x Upper Limit of Normal (ULN)
- •6.5. Billirubin less than or equal to 1.5 ULN
- •6.6. Aspartate Aminotransferase (AST) less than or equal to 2 x ULN
- •6.7. Alanine Aminotransferase (ALT) less than or equal to 2 x
排除标准
- •1. Any metastatic disease
- •2. Previous pelvic irradiation
- •3. History of other malignancy except non-melanoma skin cancer
- •4. Disease out of the pelvis and para-aortic lymph nodes
研究者
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