Pancreatic Locally Advanced Irresectable Cancer Ablation

Locally Advanced Pancreatic Cancer Clinical Trial

— PELICAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690323
• Other study ID #: NL50467.018.14
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2015
• Est. completion date: May 2020

Study information

• Verified date: September 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: IQ Molenaar, Prof. Dr.
• Phone: 0031683904242
• Email: pelican[@]dpcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: May 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	Regionaal Academisch Kankercentrum Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	IKNL, KWF, Olympus

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The period of time between randomization and death from any cause	1.5 years
Secondary	Progression free survival	The period of time between randomization and disease progression or death (by any cause)	1.5 years
Secondary	Complications	The occurence of any post-operative complications	1.5 years
Secondary	Radiological tumor response	The radiologic tumor response between start of study treatment till end of follow up (or death)	1.5 years
Secondary	Tumor marker response	The response of the tumor marker between start of study treatment till end of follow up (or death)	1.5 years
Secondary	Quality of Life questionnaire	The quality of life measured between start study treatment till end of follow up (or death)	1.5 years