At a glance
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NeoOPTIMIZE: An Open-Label, Phase II Trial to Assess the Efficacy of Adaptive Switching of FOLFIRINOX or Gemcitabine/Nab-Paclitaxel as a Neoadjuvant Strategy for Patients With Resectable and Borderline Resectable/Locally Advanced Unresectable Pancreatic Cancer
In Brief
A Phase 2 clinical trial evaluating Capecitabine, Fluorouracil, and 10 other interventions for Pancreatic Adenocarcinoma and 4 related conditions. Active but no longer recruiting, targeting 42 participants across 1 site.
Detailed Summary
This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.
Study Details
Timeline
Interventions
Given PO
Given IV
Given IV
Given IV
Given PO
Given IV
Undergo short-course or long-course RT
Undergo surgical resection
Undergo diagnostic imaging
Undergo blood sample collection
Given IV
Given IV