Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients

Summary

This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE * Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. * Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). * No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring \>1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and are negative, then enrollment can be considered after review with the study PI). Potentially Resectable Pancreatic Cancer * No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (SMA) and, if present, replaced right hepatic artery. * No involvement or \<180° interface between tumor and vessel wall of the portal vein and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence. * For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. Borderline Resectable Pancreatic Cancer * Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible occlusion of the SMV-PV. * Tumor-vessel interface \<180° of the circumference of the SMA. * Tumor-vessel interface \<180° of the circumference of the celiac artery. * Reconstructible short-segment interface of any degree between tumor and hepatic artery.

Timeline

Start

2018-08-15

Primary completion

2020-12-30

Completion

2020-12-30

Outcome

Outcome not reported

Stopped (Business): “Study was stopped due to lack of funding”

Drugs

Indications