Pancreatic Locally advanced Irresectable Cancer AblatioN (PELICAN trial)

Recruiting

Conditions: Locally advanced pancreatic cancer
non-resectabel pancreatic tumor
10017998

Registration Number: NL-OMON56404

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 174

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>survival (in months)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical: complications, toxicity of pre- and post-randomization chemotherapy,<br /><br>VAS pain score<br /><br>Pathophysiological: objective tumor reponse, progression free survival, CA 19-9<br /><br>& CEA response, immunomodulation<br /><br>Additional: quality of life, indirect and direct health costs</p><br>