Pancreatic Locally Advanced Irresectable Cancer Ablation (PELICAN)

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

Status: Unknown

Conditions: Locally Advanced Pancreatic Cancer

Treatments: Drug: Nab-paclitaxel plus Gemcitabine; Drug: FOLFIRINOX; Procedure: Radiofrequency ablation (RFA); Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03690323

NL50467.018.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas

2. Locally irresectable tumor

3. Primary tumor

4. Stable disease or partial response after 2 months of induction chemotherapy (according to RECIST)

5. 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

6. Fit for surgery assessed by the treating surgeon and anesthesiologist

7. RFA technical feasible

8. Written informed consent

9. Age ≥ 18 years

10. Expert panel approval for randomisation

Exclusion criteria

1. WHO performance status ≥ 3

2. Distant metastases on abdominal or thoracic CT scan*

3. Previous surgical, local ablative or radiotherapy for pancreatic cancer or chemotherapy which is inconsistent with the prescribed induction schedule according to protocol**

4. Stenosis of > 50% of the hepatic artery AND stenosis of >50% of the portal vein/ superior mesenteric vein

5. 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.

6. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

RFA

Experimental group

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

Treatment:

Drug: Nab-paclitaxel plus Gemcitabine

Procedure: Radiofrequency ablation (RFA)

Drug: Gemcitabine

Drug: FOLFIRINOX

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Nab-paclitaxel plus Gemcitabine

Drug: Gemcitabine

Drug: FOLFIRINOX