EUCTR2007-004299-38-GB进行中（未招募）不适用
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers. - ESPAC-4
The University of Liverpool0 个研究点目标入组 1,396 人开始时间: 2007年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,396
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1A.Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection).
- •1B.Patients who have undergone complete macroscopic resection for peri-ampullary carcinoma (R0 or R1 resection).
- •2.Completion of all pre-operative investigations.
- •3.Histological confirmation of the primary diagnosis.
- •4.Histological examination of all resection margins.
- •5.Patients randomised ideally within 12 weeks of surgery, although case by case the CI will consider patients up to 14 weeks, and can begin treatment ideally within 14 weeks of surgery.
- •6.No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs – CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation.
- •7.A WHO performance status < 2
- •8.Creatinine clearance = 50ml/min (according to Cockcroft and Gault)
- •9.Fully recovered from the operation and fit to take part in the trial.
- •10.Able to attend for administration of the adjuvant therapy.
- •11.Able to attend for long-term follow-up.
- •12.Life expectancy > 3 months.
- •13.No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
- •14.No serious medical or psychological condition precluding adjuvant treatment.
- •15.Fully informed written consent given.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 810
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 586
排除标准
- •1.Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
- •2.Patients with pancreatic lymphoma.
- •3.Macroscopically remaining tumour (R2 resection).
- •4.Patients with TNM Stage IV disease.
- •5.Patients younger than 18 years.
- •6.Pregnancy.
- •7.New York Heart Association Classification Grade III or IV.
- •8.Previous chemotherapy.
- •9.All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
- •10.Patients with known malabsorption.
- •11.Patients with neutrophil counts of <1.5 x 10^9/l.
- •12.Patients with thrombocyte counts of <100 x 10^9/l.
- •13.Patients with severe hepatic impairment.
研究者
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