Locally Advanced Pancreatic Cancer Clinical Trial
Official title:
Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03600623 -
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|
Early Phase 1 | |
| Completed |
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|
Phase 2 | |
| Not yet recruiting |
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|
N/A | |
| Not yet recruiting |
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|
Phase 2 | |
| Completed |
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|
Phase 1/Phase 2 | |
| Completed |
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|
Phase 3 | |
| Completed |
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Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.
|
Phase 2 | |
| Enrolling by invitation |
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Phase 2 | |
| Active, not recruiting |
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|
Phase 2 | |
| Recruiting |
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|
Phase 2 | |
| Active, not recruiting |
NCT03468335 -
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|
Phase 3 | |
| Not yet recruiting |
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Divestment for Artery-involved Pancreatic Cancer
|
N/A | |
| Recruiting |
NCT03257033 -
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|
Phase 3 | |
| Completed |
NCT02578732 -
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|
Phase 2 | |
| Recruiting |
NCT04789980 -
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|
||
| Completed |
NCT00644618 -
Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy
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Phase 3 | |
| Recruiting |
NCT03682289 -
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Phase 2 | |
| Terminated |
NCT02404363 -
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|
Phase 3 | |
| Active, not recruiting |
NCT06353581 -
Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX
|
Phase 2 | |
| Not yet recruiting |
NCT03815461 -
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
|
Phase 2 |