NL-OMON45151招募中3 期
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial - PREOPANC
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically or cytologically confirmed adenocarcinoma of the pancreas;2. Primarilly resectable tumours or Borderline resectable tumours ;3. Karnofsky performance status >= 70%;4. Ability to undergo surgery and radiochemotherapy;5. Leucocytes >= 3.5 X 10.9/l;6. Platelets >= 100X 10.9/l;7. Hemoglobin >= 6 mmol/l;8. renal function: E-GFR > 50 ml/min;9. Age >= 18 jaar;10.Written informed concent;11. Patients with reproductive potential must use effective contraception
排除标准
- •1.T1 resectable tumours, centrally located with no connection to the SMA, Celiac axis, CHA or SMV/PV;2. Clearly locally advanced, irresectable, tumours ;3. Carcinoma of the Papilla Vateri;4. Co morbidity precluding surgery or radiochemotherapy;5. Distant metastases, including cytologically proven N2 lymph node metastases (base of the celiac trunk or between inferior vena cava and aorta);6. Previous radiotherapy or chemotherapy precluding radiochemotherapy;7. Previous active malignancy shorter than 5 years before diagnosis of pancreatic cancer;8. Pregnancy;9. Imminent bowel obstruction;10. Active bleeding;11 Uncontrolled infection;12. Anamnestically known positive status for HIV or hepatitis B or C
研究者
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