NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the … (NCT04539808) | Clinical Trial Compass
Active — Not RecruitingPhase 2
NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
United States42 participantsStarted 2021-05-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Cytologic or histologic proof pancreatic ductal carcinoma is required prior to study entry
* If a biopsy (e.g., endoscopic ultrasound \[EUS\]-guided fine needle aspiration \[FNA\]) is planned per standard of care, the participant may be asked to consent to the additional collection of tumor tissue for research
* No evidence of metastatic disease as determined by chest computed tomography (CT) scan, abdomen/pelvis computed tomography (CT) scan (or magnetic resonance imaging \[MRI\] with gadolinium and/or manganese) within the 45-day window of study entry or prior to the one cycle of standard of care (SOC) administered before study entry, which is consistent with the standard of care
* Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, baseline radiographic imaging performed per institutional guidelines prior to SOC chemotherapy treatment may be used per investigator discretion to fulfill baseline radiographic imaging criteria even if performed \> 45 days prior to official study entry.
* Diagnostic staging laparoscopy is not required for study eligibility
* If staging laparoscopy is planned per standard of care, the participant may be asked to consent to the col…
What they're measuring
1
Proportion of Resectable or BRPC Participants With R0 Resection