Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Status:
Withdrawn
Trial end date:
2020-12-30
Target enrollment:
Participant gender:
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.