Clinical trial NCT03690323: Pancreatic Locally Advanced Irresectable Cancer Ablation
Official title: Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Pancreatic Cancer
Keywords: Pancreatic cancer
Pancreatic neoplasms
Locally advanced pancreatic cancer
Radiofrequency ablation
Chemotherapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Comprehensive Cancer Centre The Netherlands
name: Olympus
First posted: 2018-10-01
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radiofrequency ablation (RFA) plus chemotherapy versus chemotherapy monotherapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 1.5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 1.5 years
measure: Complications
timeFrame: 1.5 years
measure: Radiological tumor response
timeFrame: 1.5 years
measure: Tumor marker response
timeFrame: 1.5 years
measure: Quality of Life questionnaire
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: Regionaal Academisch Kankercentrum Utrecht
Study officials:
References:
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.