Trial | NCT03690323  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    228
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.
Study Started
Apr 07
2015
Primary Completion
Nov 30
2019
Anticipated
Study Completion
May 31
2020
Anticipated
Last Update
Oct 01
2018

Procedure Radiofrequency ablation (RFA)

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.

  • Other names: Celon ProSurge bipolar probe

Drug FOLFIRINOX [folfirinox, irinotecan (Camptosar), leucovorin, fluorouracil (efudex), oxaliplatin (eloxatin)]

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.

Drug Nab-paclitaxel plus Gemcitabine [paclitaxel (taxol), gemcitabine (gemzar)]

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.

Drug Gemcitabine

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

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

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
No Results Posted