Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer
About this trial
This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
For the initial dose escalation study, patients must have locally advanced / unresectable pancreatic cancer; these are defined as follows:
- No distant metastases
- Hepatic artery encasement
- Superior mesenteric artery (SMA) encasement > 180 degrees
- Any celiac axis abutment
- Unreconstructable superior mesenteric vein (SMV)/portal occlusion
- Aortic invasion or encasement
- Metastases to lymph nodes beyond the field of resection
For the expansion phase, patients must have borderline resectable or locally advanced / unresectable pancreatic cancer; these are defined as follows:
- No distant metastases
- At least 45 degree abutment of the hepatic artery or SMA
- Any celiac axis abutment
- Near complete occlusion of the SMV or portal vein
- Unreconstructable or reconstructible SMV/portal occlusion
- Aortic invasion or encasement
- Metastases to lymph nodes beyond the field of resection
- Patients must have evaluable disease
- Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
- Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 1
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelets (PLT) >= 100,000/ul
- Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- Bilirubin less then 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
- Serum creatinine < 1.5 x ULN
Exclusion Criteria:
- Patients who have had any prior therapy for pancreatic cancer
- Concurrent chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- Active inflammatory bowel disease
- Serious, active infections requiring treatment with IV antibiotics
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (chemoradiation and radiosurgery)
Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated IMRT 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity.