Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Mol… (NCT02723331) | Clinical Trial Compass
CompletedPhase 2
Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates
United States48 participantsStarted 2016-12-30
Plain-language summary
The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).
Who can participate
Age range18 Years – 101 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma.
✓. No evidence of distant metastasis representing stage IV metastatic disease.
✓. R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture.
✓. BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short-segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall.
✓. Age \> 18 years old
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Patients must have adequate bone marrow function:
✓. Patients must have adequate liver function:
Exclusion criteria
✕. Patients with locally advanced surgically unresectable PDAC.
What they're measuring
1
R0 Resection Rates in Each Cohort as Measured by Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins
Timeframe: at the time of surgery
Trial details
NCT IDNCT02723331
SponsorAcademic Thoracic Oncology Medical Investigators Consortium
. Patients with evidence of distant metastatic PDAC.
✕. Prior chemotherapy or radiation therapy of any kind for treatment of pancreas adenocarcinoma.
✕. Prior major surgery within 4 weeks of starting study drug administration.
✕. Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory.
✕. Concomitant treatment with full dose warfarin (coumadin) is NOT allowed. However, treatment with low molecular weight heparin (LMWH) (such as enoxaparin or dalteparin) or rivaroxaban is allowed. Patients on full dose warfarin (coumadin) must be transitioned to either LMWH or rivaroxaban prior to administration of any study related drugs.
✕. Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.