Locally Advanced Pancreatic CancerPELICANNCT03690323
Pancreatic Locally Advanced Irresectable Cancer Ablation
A study testing Radiofrequency ablation (RFA), FOLFIRINOX and Nab-paclitaxel plus Gemcitabine in people with Locally Advanced Pancreatic Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Radiofrequency ablation (RFA), FOLFIRINOX and Nab-paclitaxel plus Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 Apr 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Absolute neutrophil count: 1.5 × 109/L
Show all 14Show fewer
- Platelet count: 100 × 109/L
- Renal function: creatinine clearance> 50 ml/min
- Transaminases ≤ 3 x ULN
- Fit for surgery assessed by the treating surgeon and anesthesiologist
- RFA technical feasible
- Written informed consent
- Age ≥ 18 years
- Expert panel approval for randomisation
Who cannot join
- 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.
- Surgical exploration is not a contra-indication for inclusion
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 ZA
MGH Besselink, Prof. Dr.
- Recruiting
Regionaal Academisch Kankercentrum Utrecht
Utrecht, 3508 GA
IQ Molenaar, Prof. Dr.
About this study
Official title: Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial
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.
Read the detailed description
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.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Radiofrequency ablation (RFA), FOLFIRINOX, Nab-paclitaxel plus Gemcitabine, Gemcitabine
- Keywords
- Pancreatic cancer, Pancreatic neoplasms, Locally advanced pancreatic cancer, Radiofrequency ablation, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation (RFA)Procedure or surgery
Also called Celon ProSurge bipolar probe
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.
FOLFIRINOXDrug
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 GemcitabineDrug
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.
GemcitabineDrug
Gemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Radiofrequency ablation (RFA); Drug: FOLFIRINOX; Drug: Nab-paclitaxel plus Gemcitabine; Drug: Gemcitabine |
| Chemotherapy | Active comparator | Patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy Receives: Drug: FOLFIRINOX; Drug: Nab-paclitaxel plus Gemcitabine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The period of time between randomization and death from any cause
Measured: 1.5 years
Secondary outcomes (5)
Progression free survival
The period of time between randomization and disease progression or death (by any cause)
Measured: 1.5 years
Complications
The occurence of any post-operative complications
Measured: 1.5 years
Radiological tumor response
The radiologic tumor response between start of study treatment till end of follow up (or death)
Measured: 1.5 years
Tumor marker response
The response of the tumor marker between start of study treatment till end of follow up (or death)
Measured: 1.5 years
Quality of Life questionnaire
The quality of life measured between start study treatment till end of follow up (or death)
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start7 Apr 2015
- Primary completionNov 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Olympus
- Responsible party
- Principal investigator, I.Q. Molenaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690323
- Sponsor's protocol ID
- NL50467.018.14
- Acronym
- PELICAN
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41915391Walma 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.
PubMed 33926539
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial
- ClinicalTrials.gov ID
- NCT03690323
- Acronym / sponsor ID
- PELICAN / NL50467.018.14
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- Pancreatic cancer, Pancreatic neoplasms, Locally advanced pancreatic cancer, Radiofrequency ablation, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Olympus
- Study start
- 7 Apr 2015 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Procedure: Radiofrequency ablation (RFA), Drug: FOLFIRINOX, Drug: Nab-paclitaxel plus Gemcitabine, Drug: GemcitabineRFA: 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 | Drug: FOLFIRINOX, Drug: Nab-paclitaxel plus Gemcitabine, Drug: GemcitabinePatients will continue chemotherapy: FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation (RFA)Also: Celon ProSurge bipolar probeRFA 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. | Procedure or surgery | RFA |
| FOLFIRINOXOxaliplatin 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. | Drug | Chemotherapy, RFA |
| Nab-paclitaxel plus GemcitabineNab-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. | Drug | Chemotherapy, RFA |
| GemcitabineGemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks. | Drug | Chemotherapy, RFA |
Primary outcome
Overall survival
Time frame: 1.5 years
The period of time between randomization and death from any cause
5 secondary outcomes
Progression free survival
Time frame: 1.5 years
Complications
Time frame: 1.5 years
Radiological tumor response
Time frame: 1.5 years
Tumor marker response
Time frame: 1.5 years
Quality of Life questionnaire
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Derived from this study: PubMed 41915391Seelen 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.
- Derived from this study: PubMed 33926539Walma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation (RFA), FOLFIRINOX and Nab-paclitaxel plus Gemcitabine in people with Locally Advanced Pancreatic Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQ Molenaar, Prof. Dr. (0031683904242, pelican@dpcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690323, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.