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Pancreatic Locally Advanced Irresectable Cancer Ablation (PELICAN)

Primary Purpose

Locally Advanced Pancreatic Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Radiofrequency ablation (RFA)

FOLFIRINOX

Nab-paclitaxel plus Gemcitabine

Gemcitabine

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer focused on measuring Pancreatic cancer, Pancreatic neoplasms, Locally advanced pancreatic cancer, Radiofrequency ablation, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
- 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

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.
  - Surgical exploration is not a contra-indication for inclusion

Sites / Locations

Amsterdam UMCRecruiting
Regionaal Academisch Kankercentrum UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RFA

Chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

The period of time between randomization and death from any cause

Secondary Outcome Measures

Progression free survival

The period of time between randomization and disease progression or death (by any cause)

Complications

The occurence of any post-operative complications

Radiological tumor response

The radiologic tumor response between start of study treatment till end of follow up (or death)

Tumor marker response

The response of the tumor marker between start of study treatment till end of follow up (or death)

Quality of Life questionnaire

The quality of life measured between start study treatment till end of follow up (or death)

Full Information

NCT ID

NCT03690323

First Posted

September 25, 2018

Last Updated

September 28, 2018

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Olympus

1. Study Identification

Unique Protocol Identification Number

NCT03690323

Brief Title

Pancreatic Locally Advanced Irresectable Cancer Ablation

Acronym

PELICAN

Official Title

Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 7, 2015 (Actual)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands, Olympus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Pancreatic Cancer

Keywords

Pancreatic cancer, Pancreatic neoplasms, Locally advanced pancreatic cancer, Radiofrequency ablation, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RFA

Arm Type

Experimental

Arm Description

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation (RFA)

Other Intervention Name(s)

Celon ProSurge bipolar probe

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

FOLFIRINOX

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel plus Gemcitabine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Description

The period of time between randomization and death from any cause

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Progression free survival

Description

The period of time between randomization and disease progression or death (by any cause)

Time Frame

1.5 years

Title

Complications

Description

The occurence of any post-operative complications

Time Frame

1.5 years

Title

Radiological tumor response

Description

The radiologic tumor response between start of study treatment till end of follow up (or death)

Time Frame

1.5 years

Title

Tumor marker response

Description

The response of the tumor marker between start of study treatment till end of follow up (or death)

Time Frame

1.5 years

Title

Quality of Life questionnaire

Description

The quality of life measured between start study treatment till end of follow up (or death)

Time Frame

1.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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. Surgical exploration is not a contra-indication for inclusion

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

IQ Molenaar, Prof. Dr.

Phone

0031683904242

pelican@dpcg.nl

Facility Information:

Facility Name

Amsterdam UMC

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 ZA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MGH Besselink, Prof. Dr.

Facility Name

Regionaal Academisch Kankercentrum Utrecht

City

Utrecht

ZIP/Postal Code

3508 GA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

IQ Molenaar, Prof. Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

33926539

Citation

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.

Results Reference

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Pancreatic Locally Advanced Irresectable Cancer Ablation

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