NCT03690323

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

4.6 years

First QC Date

September 25, 2018

Last Update Submit

September 28, 2018

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Pancreatic cancerPancreatic neoplasmsLocally advanced pancreatic cancerRadiofrequency ablationChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The period of time between randomization and death from any cause

    1.5 years

Secondary Outcomes (5)

  • Progression free survival

    1.5 years

  • Complications

    1.5 years

  • Radiological tumor response

    1.5 years

  • Tumor marker response

    1.5 years

  • Quality of Life questionnaire

    1.5 years

Study Arms (2)

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

Procedure: Radiofrequency ablation (RFA)Drug: FOLFIRINOXDrug: Nab-paclitaxel plus GemcitabineDrug: Gemcitabine

Chemotherapy

ACTIVE COMPARATOR

Patients will continue chemotherapy: FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy

Drug: FOLFIRINOXDrug: Nab-paclitaxel plus GemcitabineDrug: Gemcitabine

Interventions

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.

Also known as: Celon ProSurge bipolar probe
RFA
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.

ChemotherapyRFA
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.

ChemotherapyRFA
GemcitabineDRUG

Gemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks.

ChemotherapyRFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amsterdam UMC

Amsterdam, North Holland, 1105 ZA, Netherlands

RECRUITING

Regionaal Academisch Kankercentrum Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33926539DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiofrequency Ablationfolfirinox130-nm albumin-bound paclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

IQ Molenaar, Prof. Dr.

CONTACT

0031683904242pelican@dpcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 1, 2018

Study Start

April 7, 2015

Primary Completion

November 1, 2019

Study Completion

May 1, 2020

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

NL(2)