Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct
- Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma
Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team
Criteria used to define unresectability will include, but not be limited to, the following:
- Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
- Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
- Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
- Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
- All malignant disease must be encompassed within a single radiotherapy field
- No metastatic disease
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Absolute granulocyte count > 1,500/mm³
- Platelet count > 100,000/mm³
- Creatinine clearance > 50mL/min
- AST and ALT < 5 times upper limit of normal
- Serum bilirubin < 5 mg/dL (with biliary decompression)
- INR ≤ 1.5
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
- No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus
No clinically significant cardiac disease, including the following:
- Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
- Myocardial infarction within the past 6 months
- NYHA class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])
- Atrial arrhythmia allowed provided it is well-controlled on stable medication
- No current or recent (within the past 6 months) unstable angina
- No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
- No serious nonhealing wound, ulcer, or currently healing fracture
- No AIDS
- No significant infection or other coexisting medical condition that would preclude study therapy
- No gastrointestinal fistula or perforation within the past 10 years
PRIOR CONCURRENT THERAPY:
- More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
- More than 28 days since prior major surgical procedure or open biopsy
- No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
- No prior organ transplantation
- No concurrent major surgical procedure
- No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents
Sites / Locations
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen 1
Regimen 2
Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.