2023-05-24 02:15:12
A. Background and problem definition
The standard treatment for patients with resectable pancreatic cancer (BRPC) is surgery, preceded by chemotherapy, possibly supplemented by radiation and additional chemotherapy after surgery. This is based on the results of the PREOPANC-1 study conducted in the Netherlands. There are also indications that pre-treatment with the combination chemotherapy FOLFIRINOX leads to a better survival. But despite these new developments, unfortunately, in many patients after chemotherapy, with or without radiation and surgery, the cancer eventually returns.
Several studies have shown that FOLFIRNOX improves the anti-tumor immune response in pancreatic cancer. This immunological change makes the combination of FOLFIRINOX and immunotherapy (checkpoint inhibition) interesting for further research.
Stereotactic irradiation (SBRT) is an image-guided technique that can irradiate relatively small tumors at an extremely high dose. In patients with BRPC, SBRT added to chemotherapy has been shown to be a safe and well tolerated combination. In addition, SBRT has been shown to improve the functioning of the own immune system against the cancer.
B. Research direction/proposed solution
In the PREOPANC-5 study, we want to investigate whether treatment with chemotherapy, radiation and immunotherapy before surgery, followed by surgery and chemotherapy in combination with immunotherapy, leads to a longer survival in patients with BRPC.
C. Relevance
The 5-year survival of patients with BRCP is only 20%, despite the introduction of chemo(radio)therapy prior to surgery. This study, in which a new treatment strategy will be investigated, therefore contributes to the KWF mission in which patient-oriented care is central. The new treatment strategy being investigated in the PREOPANC-5 project aims to increase the chance of a cure, longer survival and a better quality of life.
D. Research Questions
The PREOPANC-5 study aims to investigate in a safe and innovative way whether the combination of FOLFIRINOX, SBRT and checkpoint inhibition added to surgery can improve the survival of patients with resectable pancreatic cancer, while preserving quality of life.
E. Research design
In a multicenter, non-randomized phase II study, we want to investigate whether the combination of the checkpoint inhibitor pembrolizumab (4 doses), FOLFIRINOX (8 courses), and SBRT followed by surgery and postoperatively additional FOLFIRINOX (4 courses) in combination with pembrolizumab (5 doses, every 6 weeks) will lead to an improvement in progression free survival (PFS) in patients with BRCP.
F. Expected Outcomes
It is expected that patients participating in the PREOPANC-5 study will have a longer progression-free survival and a better or equal quality of life compared to historical control patients.
G. Description steps needed to implement result
The results of the PREOPANC-5 study will be submitted for publication in an international scientific journal. In addition, the study design and the (interim) results will be presented at (inter)national conferences. The study progress and results are evaluated with all parties involved during the meetings of the Dutch Pancreatic Cancer Group (DPCG). In the event of a positive study result, a randomized phase III study will follow, which will be widely rolled out across all DPCG centers in the Netherlands.
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