An interventional study of Radiofrequency ablation (RFA) and FOLFIRINOX in Locally Advanced Pancreatic Cancer, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-01.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 228 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Fit for chemotherapy as assessed by the medical oncologist, plus:
Exclusion Criteria:
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.
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
Procedure: Radiofrequency ablation (RFA) · Drug: FOLFIRINOX · Drug: Nab-paclitaxel plus Gemcitabine · Drug: Gemcitabine
Patients will continue chemotherapy: FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy
Drug: FOLFIRINOX · Drug: Nab-paclitaxel plus Gemcitabine · Drug: Gemcitabine
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.
Also known as: Celon ProSurge bipolar probe
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 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 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks.
Overall survival
The period of time between randomization and death from any cause
Time frame: 1.5 years
Progression free survival
The period of time between randomization and disease progression or death (by any cause)
Time frame: 1.5 years
Complications
The occurence of any post-operative complications
Time frame: 1.5 years
Radiological tumor response
The radiologic tumor response between start of study treatment till end of follow up (or death)
Time frame: 1.5 years
Tumor marker response
The response of the tumor marker between start of study treatment till end of follow up (or death)
Time frame: 1.5 years
Quality of Life questionnaire
The quality of life measured between start study treatment till end of follow up (or death)
Time frame: 1.5 years
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)