Status:
COMPLETED
Perioperative Therapy for Resectable Pancreatic Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer ...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection a...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)
- Resectable Disease- Head/Body/Tail of pancreas:
- No distant metastases
- Clear fat plane around celiac and superior mesenteric arteries (SMA)
- Patent superior mesenteric vein (SMV) and portal vein (PV)
- Borderline Resectable Disease -Head/Body of pancreas:
- Tumor abutment on SMA
- SMV/portal vein impingement or occlusion if involving only a short segment, with open vein both proximally and distally (if proximal vein is occluded up to the portal vein branches then disease is unresectable)
- Colon or mesocolon invasion
- Gastroduodenal artery (GDA) encasement up to origin at hepatic artery
- Tail of pancreas:
- Adrenal, colon or mesocolon, or kidney invasion
- Preoperative evidence of biopsy-positive peripancreatic lymph node
- No prior therapy for pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Leucocytes \>= 3,000/uL
- Absolute Neutrophil Count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total Bilirubin:
- If within normal limits (WNL) to =\< 2.0, the subject is eligible
- If \> 2.0 - \< 6.0, subject is eligible IF they have a biliary stent and total bilirubin is decreasing
- If \>= 6.0, subject is not eligible
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal or =\< 1.5 X upper limit of normal (ULN) if alkaline phosphatase (Alk Phos) \> 2.5 X ULN or if the subject has a biliary stent and the liver function tests (LFTs) are decreasing the subject is eligible
- Creatinine clearance \>= 30%
- Negative pregnancy test for women of childbearing potential; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to swallow and retain oral medication
- Ability to understand and willingness to sign a written informed consent document
Exclusion
- Patients may not be receiving any other investigational agents
- Histology other than adenocarcinoma
- Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)
- Unresectable disease
- Head of pancreas:
- Distant metastases (includes celiac and/or para-aortic)
- SMA, celiac encasement
- SMV/portal occlusion
- Aortic, inferior vena cava (IVC) invasion or encasement
- Invasion of SMV below transverse mesocolon
- Body of pancreas:
- Distant metastases (includes celiac and/or para-aortic); at the discretion of the treating surgeon, body and tail lesions that have positive celiac and/or para-aortic nodes in close vicinity to the primary may be borderline rather than unresectable
- SMA, celiac, hepatic encasement
- SMV/portal extended occlusion
- Aortic invasion
- Tail of pancreas:
- Distant metastases (includes celiac and/or para-aortic)
- SMA, celiac encasement
- Rib, vertebral invasion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study
- Patients who have received prior chemotherapy or radiotherapy for the diagnosis of pancreatic cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Inability to comply with study and/or follow-up procedures
- Pregnancy or lactation
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00609336
Start Date
January 1 2008
End Date
December 1 2016
Last Update
July 13 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109