NL-OMON56404
Recruiting
Not Applicable
Pancreatic Locally advanced Irresectable Cancer AblatioN (PELICAN trial) - PELICAN trial
Amsterdam UMC0 sites174 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Locally advanced pancreatic cancer
- Sponsor
- Amsterdam UMC
- Enrollment
- 174
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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