Carbon Ion or Conventional Photon Radiation Therapy and Chemotherapy in Treating Patients with Locally Advanced, Unresectable Pancreatic Cancer

Inclusion Criteria

• All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol
• Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration
• Unresectable by radiographic or exploration within 30 days of registration
• Distance from the pancreas tumor edge to the bowel and stomach >= 3 mm
• Tumor does not exceed 15 cm in greatest dimension
• No evidence for metastatic disease as assessed by computed tomography (CT) imaging of the chest, abdomen and pelvis OR by positron emission tomography (PET)-CT within the 30 days prior to registration. Pancreas-protocol CT or magnetic resonance imaging (MRI) with gadolinium (for patients who cannot receive CT contrast) is required as part of this evaluation
• Zubrod performance status of 0-1, within 30 days prior to registration
• Absolute neutrophil count >= 1500 cells/mm^3
• Creatinine < 1.5 mg/dL
• Hemoglobin >= 8.0 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 X upper limit of normal (ULN) (obtained within 14 days prior to registration [may be taken after stent placement])
• Bilirubin =< 1.5 times the ULN (after stent placement, if necessary)
• Patients must complete all required pretreatment evaluations
• Able to travel to a foreign country within approximately 4 weeks of randomization (for patients enrolled outside of Japan and Italy)
• If a patient receives 1 or 2 cycles of chemotherapy at an outside facility, pre-treatment laboratory values must meet the above criteria. If the protocol-compliant imaging had not been obtained prior to chemotherapy, they may be performed prior to registration and any additional chemotherapy being infused
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria

• Subjects receiving other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study
• Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Prior radiation to the upper abdomen
• Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy)
• Body weight > 100 kg
• Active inflammatory bowel disease or active gastric/duodenal ulcer
• Metal implants in the upper abdomen
• Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy
• History of human immunodeficiency virus (HIV) or hepatitis B or C