Pancreatic Locally advanced Irresectable Cancer AblatioN (PELICAN trial) - PELICAN trial

Amsterdam UMC0 个研究点目标入组 174 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2.
•Locally irresectable tumor (see Appendix 1 of the protocol for criteria) 3.
•Primary tumor 4. Stable disease or partial respons after 2 months of induction
•chemotherapy (according to RECIST) 5. Fit for chemotherapy as assessed by the
•medical oncologist plus: • Absolute neutrophil count >= 1.5 × 10^9/L • Platelet
•count >= 100 × 10^9/L • Renal function: creatinine clearance > 50 ml/min •
•Transaminases <= 3 x ULN 6. Fit for surgery assessed by the treating surgeon and
•anesthesiologist 7. RFA technical feasible (see Appendix 2 of the protocol for
•criteria) 8. Written informed consent 9. Age >= 18 years

•1. WHO performance status 3 or 4 2. Distant metastases on abdominal or thoracic
•CT scan* 3. Previous surgical, local ablative or radiotherapy for pancreatic
•cancer or chemotherapy which is inconsistent with the prescribed induction
•schedule according to protocol** 4. Stenosis of > 50% of the hepatic artery AND
•portal vein/ superior mesenteric vein 5. Second primary malignancy, except
•adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix
•uteri or other malignancies treated at least 5 years previously without signs
•of recurrence. 6. Pregnancy * Positive or suspicious regional lymph node
•metastases are not a reason for exclusion ** Surgical exploration is not a
•contra-indication for inclusion kan zij

发起方

Amsterdam UMC