EUCTR2007-004299-38-SE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 cancer. - ESPAC-4
The University of Liverpool0 个研究点目标入组 1,080 人开始时间: 2009年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,080
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. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (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. No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.
- •6. A WHO performance status < or equal to 2.
- •7. Creatinie clearence > or equal to 50 ml/min (according to Cockcroft and Gault).
- •8. Fully recovered from the operation and fit to take part in the trial.
- •9. Able to attend for administration of the adjuvant therapy.
- •10. Able to attend for long-term follow-up.
- •11. Life expectancy > 3 months.
- •12. No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
- •13. No serious medical or psychological condition precluding adjuvant treatment.
- •14. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
相似试验
进行中（未招募）
不适用
A trial comparing the current standard treatment (gemcitabine) to the experimental, combined treatments of gemcitabine plus capecitabine.Resectable pancreatic or peri-ampullary cancersMedDRA version: 14.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10034446Term: Periampullary carcinoma resectableSystem Organ Class: 100000004864EUCTR2007-004299-38-GBThe University of Liverpool1,396
进行中（未招募）
1 期
Comparing Gemcetabine and Capecitabine versus Gemcitabine monotherapy in chemotherapy for pancreatic cancerResectable pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864EUCTR2007-004299-38-DEThe University of Liverpool1,068
进行中（未招募）
不适用
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer. - ESPAC-4Resectable pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableEUCTR2007-004299-38-FIThe University of Liverpool1,080
尚未招募
3 期
Comparision of combination chemotherapy with single chemotherapy following Surgery for pancreatic and Periampullary cancerCTRI/2017/10/010016Tata Memorial Hospital
招募中
2 期
PAT-07Borderline resectable pancreatic cancerBorderline resectable, pancreatic cancerD021441JPRN-jRCTs041200028Kodera Yasuhiro50