EUCTR2007-004299-38-DE进行中（未招募）1 期
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic ductal and peri-ampullary cancers. - ESPAC-4
The University of Liverpool0 个研究点目标入组 1,068 人开始时间: 2011年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,068
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
- •1.A) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)
- •B) 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 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, or equivalent value following local practice).
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 534
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 534
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 a baseline neutrophil count of <1.5 x 109/l.
- •12.Patients with a baseline platelet count of <100 x 109/l.
- •13.Patients with severe hepatic impairment.
研究者
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