Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
Author Information
Author(s): Jeremy L Davis, Prakash Pandalai, Taylor R Ripley, Russell C Langan, Seth M Steinberg, Melissa Walker, Mary Ann Toomey, Elliot Levy, Itzhak Avital
Primary Institution: National Cancer Institute, NIH, Bethesda, MD, USA
Hypothesis
Neoadjuvant regional chemotherapy with continuous infusion of gemcitabine will be well tolerated and may improve resectability rates in cases of locally advanced pancreatic cancer.
Conclusion
The study aims to evaluate the safety and efficacy of selective regional infusion of gemcitabine in patients with locally advanced, unresectable pancreatic cancer.
Supporting Evidence
- Less than twenty percent of patients are considered operative candidates at the time of diagnosis.
- Phase I studies have shown regional administration of chemotherapy to be safe.
- The average reported response rate was approximately 26%.
Takeaway
This study is trying to find out if giving chemotherapy directly to the pancreas can help more people with advanced pancreatic cancer have surgery to remove their tumors.
Methodology
This is a phase I trial designed to evaluate the feasibility and toxicity of super-selective intra-arterial administration of gemcitabine in patients with locally advanced, unresectable pancreatic adenocarcinoma.
Potential Biases
The majority of studies were small series or sequential, uncontrolled trials, which may introduce bias.
Limitations
The analysis of heterogeneous reports of a non-standardized treatment strategy is limited by inherent bias and the retrospective nature of the review.
Participant Demographics
The majority of patients were diagnosed with pancreatic ductal adenocarcinoma, with over 95% having locally advanced or metastatic cancer.
Statistical Information
P-Value
p = 0.013
Digital Object Identifier (DOI)
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