Pancreatic cancer
Conditions
Interventions
radiofrequency ablation plus standard palliative chemotherapy
Sponsors
Olympus Medical Systems: CelonPowerSystem; CelonProSurge probes
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2. Locally irresectable tumor (according to the Dutch Pancreatic Cancer Group criteria; www.dpcg.nl) 3. Primary tumor 4. Stable disease or partial response after 2 months of induction chemotherapy (according to RECIST) 5. Fit for chemotherapy as assessed by the medical oncologist, plus: • Absolute neutrophil count at least 1.5 × 109/L • Platelet count at least 100 × 109/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 for criteria) 8. Written informed consent 9. 18 years or older 10. Expert panel approval for randomisation
Exclusion criteria
Exclusion criteria: 1. WHO performance status ≥ 3 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 stenosis of >50% of the 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 *Suspicious or pPositive regional lymph nodes metastases are not a reason for exclusion. Suspicious lymph nodes only on radiologic basis are not considered as metastasis. Only when suspicion is high due to large infiltration, pathological examination by FNA can be considered. Pathologic proven positive station 16 and 9 lymph nodes are considered as M+ disease. ** Surgical exploration is not a contra-indication for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical • Postoperative complications • Toxicity of post-randomization chemotherapy • Visual Analogue Scale (VAS) pain score • Symptom free survival 2. Pathophysiological • Objective Tumor Response (RECIST criteria [38,39]) • Progression free survival (RECIST criteria [38,39]) • CA 19-9 & CEA response • Immunomodulating factors 3. Additional: • Time between randomization and start of study treatment • Quality of life as measured by validated questionnaires • Indirect and direct health costs | — |
Contacts
Public ContactLilly Brada
UMCU/AMC
Outcome results
None listed