Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at MDACC, including triphasic CT demonstrating tumor abutment of the superior mesenteric artery (SMA) or celiac axis, superior mesenteric vein (SMV) or portal vein (PV) involvement which is not resectable without vascular reconstruction.
Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of > degrees (> %) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or portal vein (PV) involvement
Resectable primary tumor of the head, body or tail of the pancreas defined per National Comprehensive Cancer Network (NCCN) guidelines version .:\r\n* No extra-pancreatic disease, aside from lymphadenopathy\r\n* No arterial tumor contact (celiac axis, superior mesenteric artery, or common hepatic artery)\r\n* No tumor contact with the superior mesenteric vein or portal vein or =< degree contact without vein contour irregularity
Tumors must be localized (non-metastatic) and classified as borderline resectable according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound\r\n* AHPBA/SSO/SSAT criteria (any one of the following):\r\n** Tumor-associated deformity of the SMV (superior mesenteric vein) or PV (portal vein)\r\n** Abutment of the SMV or PV >= degrees\r\n** Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction\r\n** Short-segment involvement of the hepatic artery or its branches amenable to resection and reconstruction\r\n** Abutment of the superior mesenteric artery (SMA) < degrees
Subjects with locally advanced, unresectable primary tumors will not be eligible\r\n* This includes any of the following:\r\n** Abutment of the SMA >= degrees\r\n** Occlusion of the SMV or PV with insufficient normal vein above and below with which to perform venous reconstruction\r\n** Involvement of the hepatic artery with insufficient artery proximal and distal to perform reconstruction
Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist; criteria defining unresectable and borderline resectable patients will be based on the National Comprehensive Cancer Network (NCCN) Guidelines (version [v] .)\r\n* Unresectable\r\n** Greater than degrees of superior mesenteric artery (SMA) encasement\r\n** Any celiac abutment\r\n** Unreconstructible superior mesenteric vein (SMV)/portal occlusion\r\n** Aortic invasion or encasement\r\n** Nodal metastases beyond the field of resection\r\n* Borderline resectable\r\n** Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen\r\n** Encasement of the SMV/portal vein but without encasement of the nearby arteries\r\n** Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting.\r\n** Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis\r\n** Tumor abutment to SMA but not to exceed greater than degrees of circumferential vessel wall
Borderline-resectable or locally-advanced pancreatic cancer (based upon impression of the surgical oncologist, in conjunction with radiologic consultations) as defined per the Alliance consensus:\r\n* Borderline-resectable\r\n** An interface between the primary tumor and superior mesenteric vein (SMV)/portal vein measuring degrees or greater of the circumference of the vein wall\r\n** Short-segment occlusion of the SMV/portal vein but with suitable vessel proximal and distal to the obstruction to allow safe resection and reconstruction\r\n** Short-segment interface (of any degree) between the tumor and the hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction\r\n** An interface between the tumor and the superior mesenteric artery (SMA) or celiac trunk measuring less than degrees of the circumference of the artery wall \r\n* Locally-advanced\r\n** Encasement of the SMA/celiac artery (> degrees)\r\n** Involvement of the SMV/portal vein without options for reconstruction\r\n** Aortic invasion or encasement
Resectable pancreatic adenocarcinoma disease as defined as follows:\r\n* No evidence of extrapancreatic disease by cross sectional imaging, PET scan, or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases;\r\n* No evidence of tumor extension to superior mesenteric artery, hepatic artery, celiac axis, aorta, or inferior vena cava, and no evidence of occlusion or encasement of the superior mesenteric vein or superior mesenteric vein/portal vein confluence, as assessed by computed tomography (CT) using pancreatic protocol (or magnetic resonance imaging [MRI] in patients who cannot undergo CT) and EUS
Patients will have unresectable disease, defined radiographically as > degrees involvement of the superior mesenteric artery or celiac trunk or superior mesenteric vein (SMV)/portal vein impingement that cannot be surgically reconstructed, in the absence of distant metastasis
Borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (no distant metastases, venous involvement of the portal vein/superior mesenteric vein [SMV], demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the superior mesenteric artery [SMA] not to exceed degrees of the circumference of the vessel wall)
Disease should be determined as \borderline resectable\ according to the Expert Consensus Statement published by Callery et al:\r\n* No distant metastasis\r\n* Venous involvement of the superior mesenteric vein (SMV)/portal vein demonstrating tumor abutment with or without impingement and narrowing of the lumen, encasement of the SMV/portal vein but without encasement of the nearby arteries, or short segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection and reconstruction\r\n* Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis\r\n* Tumor abutment of the superior mesenteric artery (SMA) not to exceed greater than degrees of the circumference of the vessel wall
Patients must have non-metastatic pancreatic cancer not immediately amenable to surgical resection; these are defined as follows\r\n* No distant metastases\r\n* Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels:\r\n** Hepatic artery \r\n** Superior mesenteric artery \r\n** Celiac axis \r\n** Superior mesenteric vein \r\n** Aorta\r\n* Metastases to lymph nodes beyond the field of resection
Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis; the local interpreting radiologist must review the scans and sign the S local radiology checklist prior to registration; resectable is defined as:\r\n* No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)\r\n* No involvement, or < degrees interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence\r\n* No evidence of metastatic disease; lymphadenopathy (defined as nodes measuring > cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M disease and makes the patient ineligible; if, however, such nodes are biopsied and are negative, then enrollment can be considered after review with the study chairs\r\n* Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease
One of the following:\r\n* Upfront resectable disease; this is defined as:\r\n** No arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA]); AND\r\n** No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV), or =< degree contact without vein contour irregularity\r\n* Borderline resectable disease; There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract; borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT); per this trial, borderline resectable PDAC is defined as the presence of any one or more of the following on CT or MRI:\r\n** An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring >= degrees of the circumference of the vessel wall\r\n** 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\r\n** 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 reconstruction\r\n** An interface between the tumor and SMA measuring < degrees of the circumference of the vessel wall
The primary tumor must be resectable, defined as no involvement (abutment or encasement) of the major arteries (celiac, common hepatic, superior mesenteric) and interface between tumor and vessel (portal, superior mesenteric veins) wall to be less than degrees of the circumference of the vessel wall; this should be confirmed by imaging of the abdomen, either by a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan; PET scans will not be adequate alternatives; for each patient, the resectability must be reviewed by one of the study surgeons
Locally advanced, unresectable pancreatic cancer defined on post-induction chemotherapy computed tomography (CT) as having tumor involvement of > degrees (> %) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or pemphigus vulgaris (PV) involvement
Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen, encasement of the SMV/portal vein but without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection and reconstruction
Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery without extension to the celiac axis.
Tumor abutment of the SMA not to exceed greater than degrees of the circumference of the vessel wall.
Head: Greater than degrees SMA encasement or any celiac abutment or unreconstructible SMV/portal occlusion or aortic invasion or encasement.
Body: Greater than degrees SMA or celiac encasement or unreconstructible SMV/portal occlusion or aortic invasion.
Tail: SMA or celiac encasement greater than degrees.
Patients with locally advanced, unresectable disease will be included; locally advanced unresectable disease is defined by the National Comprehensive Cancer Network (NCCN) as:\r\n* Tumors of the head that have greater than degrees of superior mesenteric artery (SMA) encasement or any celiac abutment, unreconstructable superior mesenteric vein (SMV) or portal occlusion, or aortic invasion or encasement\r\n* Tumors of the body with SMA or celiac encasement of greater than degrees, unreconstructable SMV or portal occlusion, or aortic invasion\r\n* Tumors of the tail with SMA or celiac encasement of greater than degrees\r\n* Irrespective of location, all tumors with evidence of nodal metastasis outside of the resection field are deemed unresectable
A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed)
A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
Patients who are deemed \borderline resectable\ will be included; borderline resectable is defined by the NCCN as tumors with venous involvement of the superior mesenteric vein (SMV)/portal vein demonstrating tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the superior mesenteric artery (SMA) not to exceed greater than degrees of the circumference of the vessel wall; tumors involving retroperitoneal structures that can be surgically removed (ie. kidney), will also be included
Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for the study; for this study, such patients are defined as those who meet one or more of the following radiographic or serologic criteria:\r\n* Primary tumor that involves the superior mesenteric vein causing a vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction\r\n* Primary tumor that involves =< degrees of the superior mesenteric artery (SMA), celiac axis or any of its branches on CT or magnetic resonance imaging (MRI)\r\n* Primary tumor that abuts or encases (>= % of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin)\r\n* Patients with a high cancer antigen - (CA-) (>= mg/dl) in the presence of a bilirubin =< . mg/dL\r\n* Radiographic findings consistent with malignant peripancreatic lymphadenopathy outside the planned field on CT or MRI\r\n* Radiographic findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not diagnostic of metastatic disease
Patients must have borderline resectable pancreatic adenocarcinoma defined by one of the following criteria: \r\n* Tumor associated deformity of the superior mesenteric vein (SMV) or portal vein (PV) \r\n* Abutment of the SMV or PV =< degrees \r\n* Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction \r\n* Short-segment involvement of the hepatic artery or its branches amenable to resection and reconstruction or \r\n* Abutment of the superior mesenteric artery (SMA) =< degrees
Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen, encasement of the SMV/portal vein but without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection and reconstruction
Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery without extension to the celiac axis.
Tumor abutment of the SMA not to exceed greater than degrees of the circumference of the vessel wall.
Head: Greater than degrees SMA encasement or any celiac abutment or unreconstructible SMV/portal occlusion or aortic invasion or encasement.
Body: Greater than degrees SMA or celiac encasement or unreconstructible SMV/portal occlusion or aortic invasion.
Tail: SMA or celiac encasement greater than degrees.
Definition of localized, potentially resectable disease:\r\n* Staging by intravenous contrast-enhanced thin section helical abdominal computed tomography (. mm cuts or less) or magnetic resonance imaging (MRI) (for patients with an IV contrast allergy) using pancreatic protocol; endoscopic ultrasound is required for tissue acquisition and staging confirmation\r\n* No extension to superior mesenteric artery (SMA) and hepatic artery; patent superior mesenteric vein/portal vein (SMV/PV) with < -degree abutment and no evidence of invasion\r\n* Clear fat plane between the SMA and celiac axis\r\n* No extension to celiac axis and hepatic artery\r\n* Patent superior mesenteric vein and portal vein\r\n* No evidence of distant disease
Borderline resectable disease as defined by:\r\n* Staging by intravenous contrast-enhanced thin section helical abdominal computed tomography (. mm cuts or less) or magnetic resonance imaging (MRI) (for patients with an IV contrast allergy) using pancreatic protocol; endoscopic ultrasound is required for tissue acquisition and staging confirmation:\r\n** American Joint Committee on Cancer (AJCC) stage II\r\n** May have abutment of the superior mesenteric artery (SMA); abutment must be < \r\n** Abutment of the celiac axis\r\n** May have abutment or short segment encasement of the common hepatic artery (CHA) \r\n** May have short segment occlusion of the superior mesenteric vein (SMV)-portal vein (PV) confluence if reconstruction is possible\r\n** No evidence of distant disease
Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on computed tomography (CT) as having tumor abutment of > degrees (> %) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or portal vein (PV) involvement
Patients must have resectable pancreatic cancer OR must be deemed borderline resectable; potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery (SMA),and c) no evidence (CT or MRI) of occlusion of the superior mesenteric vein (SMV) or superior mesentericportal vein (SMPV) confluence; borderline resectable is defined by the National Comprehensive Cancer Network (NCCN) as tumors with venous involvement of the SMV/portal vein demonstrating tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the SMA not to exceed greater than degrees of the circumference of the vessel wall; tumors involving retroperitoneal structures that can be surgically removed (ie. kidney), will also be included
Resectable pancreatic ductal adenocarcinoma (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
Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC): defined as localized PDAC with or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring degrees 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 degrees of the circumference of the artery wall