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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
| Comprehensive Cancer Centre The Netherlands | OTHER |
| Olympus | INDUSTRY |
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The aim of the PELICAN trial is to investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC after 2 months of induction chemotherapy.
Pancreatic cancer is the fifth leading cause of cancer-related death in the Netherlands. Each year around 900 patients in the Netherlands are diagnosed with irresectable locally advanced pancreatic cancer (LAPC), which has a median survival of 7.9 months. Standard treatment is palliative chemotherapy, which offers only a very limited survival benefit. Radiofrequency ablation (RFA) is a new ablative technique for LAPC, which is feasible and safe and has been suggested to improve survival. A randomized controlled trial has not yet been performed.
The aim of the PELICAN trial is to investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC after 2 months of induction chemotherapy. In a randomized controlled parallel-group superiority multicenter phase III clinical trial.
The intervention will be RFA followed by chemotherapy (gemcitabine monotherapy, nab-paclitaxel plus gemcitabine or FOLFIRINOX). The comparison will be standard palliative treatment consisting of gemcitabine monotherapy, nab-gemcitabine plus gemcitabine or FOLFIRINOX Primary endpoint: Overall survival. Secondary endpoints: Progression free survival, complications, pain, radiological tumor response, CA-19.9 and CEA response, quality of life, immunomodulation and total direct and indirect costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA | Experimental | RFA: laparotomy is performed followed by radiofrequency ablation of the tumor. After recovery of the RFA patients will continue chemotherapy: FOLFIRINOX or nab-paclitaxel + gemcitabine or gemcitabine monotherapy |
|
| Chemotherapy | Active Comparator | Patients will continue chemotherapy: FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation (RFA) | Procedure | RFA involves the implantation of electrodes directly into the tumor, with the use of intra-operative ultrasound. The electrodes produce a high frequency alternating current, which leads to frictional heating and thus tissue destruction by thermal coagulation and protein denaturation. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The period of time between randomization and death from any cause | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | The period of time between randomization and disease progression or death (by any cause) | 1.5 years |
| Complications | The occurence of any post-operative complications |
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Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Locally irresectable tumor
Primary tumor
Stable disease or partial response after 2 months of induction chemotherapy (according to RECIST)
Fit for chemotherapy as assessed by the medical oncologist, plus:
Fit for surgery assessed by the treating surgeon and anesthesiologist
RFA technical feasible
Written informed consent
Age ≥ 18 years
Expert panel approval for randomisation
Exclusion Criteria:
WHO performance status ≥ 3
Distant metastases on abdominal or thoracic CT scan*
Previous surgical, local ablative or radiotherapy for pancreatic cancer or chemotherapy which is inconsistent with the prescribed induction schedule according to protocol**
Stenosis of > 50% of the hepatic artery AND stenosis of >50% of the portal vein/ superior mesenteric vein
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.
Pregnancy
Positive regional lymph nodes metastases are not a reason for exclusion. Lymph nodes are considered as regional, according to the consensus statement by the International Study Group of Pancreatic Surgery (ISGPS). 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IQ Molenaar, Prof. Dr. | Contact | 0031683904242 | pelican@dpcg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41915391 | Derived | Seelen LWF, Brada LJH, Walma MS, Rombouts SJE, Braat MN, Bollen TL, Borel Rinkes IH, Bruijnen RCG, Busch OR, Cirkel GA, Daamen LA, Daams F, van Dam RM, van Delden OM, Derksen WJM, Festen S, Groothuis K, Hagendoorn J, de Hingh IHJT, D'Hondt M, Liem MSL, van Lienden KP, Los M, de Meijer VE, Mekenkamp LJM, Nijkamp MW, Nio CY, Pando E, Patijn GA, Polee MB, Te Riele WW, Roeyen G, Stommel MWJ, de Vos-Geelen J, de Vries JJ, Wessels FJ, Wilmink JW, van de Ven PM, Besselink MG, van Santvoort HC, Molenaar IQ; Dutch Pancreatic Cancer Group. Radiofrequency Ablation and Chemotherapy vs Chemotherapy Only in Locally Advanced Pancreatic Cancer: The PELICAN Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263861. doi: 10.1001/jamanetworkopen.2026.3861. | |
| 33926539 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| C000627770 | folfirinox |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy
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|
|
| FOLFIRINOX | Drug | Oxaliplatin 85mg/m2 given as 2-hour IV infusion, followed by leucovorin 400mg/m2 given as 2-hour IV infusion with addition of irinotecan 180mg/m2 given as 90-minute IV infusion. Followed by fluorouracil 400mg/m2 IV bolus, followed by continuous IV infusion of 2400mg/m2 during 46-hour. Every 2 weeks. |
|
| Nab-paclitaxel plus Gemcitabine | Drug | Nab-paclitaxel 125mg/m2 given as 30-40-minute IV infusion, followed by gemcitabine 1000mg/m2 IV infusion. On day 1, 8 and 15 every 4 weeks. |
|
| Gemcitabine | Drug | Gemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks. |
|
| 1.5 years |
| Radiological tumor response | The radiologic tumor response between start of study treatment till end of follow up (or death) | 1.5 years |
| Tumor marker response | The response of the tumor marker between start of study treatment till end of follow up (or death) | 1.5 years |
| Quality of Life questionnaire | The quality of life measured between start study treatment till end of follow up (or death) | 1.5 years |
| Regionaal Academisch Kankercentrum Utrecht | Recruiting | Utrecht | 3508 GA | Netherlands |
|
| Derived |
| Walma MS, Rombouts SJ, Brada LJH, Borel Rinkes IH, Bosscha K, Bruijnen RC, Busch OR, Creemers GJ, Daams F, van Dam RM, van Delden OM, Festen S, Ghorbani P, de Groot DJ, de Groot JWB, Haj Mohammad N, van Hillegersberg R, de Hingh IH, D'Hondt M, Kerver ED, van Leeuwen MS, Liem MS, van Lienden KP, Los M, de Meijer VE, Meijerink MR, Mekenkamp LJ, Nio CY, Oulad Abdennabi I, Pando E, Patijn GA, Polee MB, Pruijt JF, Roeyen G, Ropela JA, Stommel MWJ, de Vos-Geelen J, de Vries JJ, van der Waal EM, Wessels FJ, Wilmink JW, van Santvoort HC, Besselink MG, Molenaar IQ; Dutch Pancreatic Cancer Group. Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial. Trials. 2021 Apr 29;22(1):313. doi: 10.1186/s13063-021-05248-y. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |