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PELICAN trial; local ablative treatment of an inoperable pancreascarcinoma; lokale verbranding van een niet-operabel alvleeskliertumor


- candidate number23544
- NTR NumberNTR5517
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2015
- Secondary IDsUU2014-7444; NL50467.018.14 KWF; CCMO register
- Public TitlePELICAN trial; local ablative treatment of an inoperable pancreascarcinoma; lokale verbranding van een niet-operabel alvleeskliertumor
- Scientific TitlePancreatic Locally advanced Irresectable Cancer Ablation in the Netherlands
- ACRONYMPELICAN trial
- hypothesisTo investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer
- Inclusion criteria1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Locally irresectable tumor (according to the Dutch Pancreatic Cancer Group criteria; www.dpcg.nl)
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 at least 1.5 109/L
Platelet count at least 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 (see Appendix 2 for criteria)
8. Written informed consent
9. 18 years or older
10. Expert panel approval for randomisation
- Exclusion criteria1. 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
*Suspicious or pPositive regional lymph nodes metastases are not a reason for exclusion. 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. Pathologic proven positive station 16 and 9 lymph nodes are considered as M+ disease. ** Surgical exploration is not a contra-indication for inclusion
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-apr-2015
- planned closingdate6-mei-2019
- Target number of participants228
- Interventionsradiofrequency ablation plus standard palliative chemotherapy
- Primary outcomeOverall survival
- Secondary outcome1. Clinical
Postoperative complications
Toxicity of post-randomization chemotherapy
Visual Analogue Scale (VAS) pain score
Symptom free survival
2. Pathophysiological
Objective Tumor Response (RECIST criteria [38,39])
Progression free survival (RECIST criteria [38,39])
CA 19-9 & CEA response
Immunomodulating factors
3. Additional:
Time between randomization and start of study treatment
Quality of life as measured by validated questionnaires
Indirect and direct health costs
- Timepointsrandomisation; start studytreatment (RFA + chemo, or chemo alone); 1, 3, 6, 12 and 18 months after start studytreatment
- Trial web sitewww.pelicantrial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Steffi Rombouts
- CONTACT for SCIENTIFIC QUERIES Steffi Rombouts
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publicationsnot yet
- Brief summaryRationale: 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.

Objective: To investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC.

Study design: A randomized controlled parallel-group superiority multicenter phase III clinical trial

Study population: Patients with LAPC without distant metastases following 2 months of induction therapy consisting of gemcitabine monotherapy, nab-paclitaxel plus gemcitabine or FOLFIRINOX.

Intervention: RFA followed by gemcitabine monotherapy, nab-paclitaxel plus gemcitabine or FOLFIRINOX Comparison: Standard palliative treatment consisting of gemcitabine monotherapy, nab-gemcitabine plus gemcitabine or FOLFIRINOX

Primary endpoint: Overall survival defined as the period of time between randomization and death from any cause 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.

Relevance: Each year 900 patients are diagnosed with LAPC, which has a poor prognosis. Current treatment options are limited and provide only a marginal survival benefit. RFA is a potential technique that may increase survival significantly with a limited risk of complications.
- Main changes (audit trail)
- RECORD29-dec-2015 - 27-jan-2016


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