ISRCTN11513444已完成不适用
A phase III, multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer
Sponsor not defined (UK)0 个研究点目标入组 508 人开始时间: 2005年11月21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
- 508
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
- All
入选标准
- •1. Age >18 years
- •2. Histologically or cytologically proven ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- •3. The presence of locally advanced or metastatic disease precluding curative surgical resection
- •4. Patients with macroscopic residual disease following resection confirmed by positive histology in post-resection tissue biopsies from the tumour bed (R2 resection) are also eligible
- •5. Unidimensionally measurable disease as assessed by computed tomography (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. The only exception will be for patients with an R2 resection who will be evaluated for survival only.
- •6. No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication
- •7. No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment
- •8. World Health Organisation (WHO) performance status 0, 1 or 2
- •9. Adequate bone marrow function with platelets >100 x 10^9/l; white blood cells (WBC) >3 x 10^9/l; neutrophils >1.5 x 10^9/l at the time of study entry
- •10. Serum bilirubin <35 µmol/l
- •11. Serum creatinine <180 µmol/l and calculated creatinine clearance over 50 ml/min
- •12. No concurrent uncontrolled medical condition
- •13. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
- •14. Life expectancy >3 months
- •15. Adequate contraceptive precautions if relevant
- •16. Informed written consent
排除标准
- •1. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
- •2. Intracerebral metastases or meningeal carcinomatosis
- •3. New York Heart Association classification Grade III or IV
- •4. Uncontrolled angina pectoris
- •5. Pregnancy or breast feeding
- •6. Impaired renal function with calculated creatinine clearance less than 50 ml/min
- •7. Previous investigational study drug
- •8. Known malabsorption syndromes
- •9. Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency
研究者
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