Locally advanced pancreatic cancer
Conditions
Interventions
Radiofrequency ablation, which is performed through a median laparotomy
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion 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 = 18 years
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival (in months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: complications, toxicity of pre- and post-randomization chemotherapy, VAS pain score Pathophysiological: objective tumor reponse, progression free survival, CA 19-9 & CEA response, immunomodulation Additional: quality of life, indirect and direct health costs | — |
Countries
Netherlands
Outcome results
None listed