Trial of Carbon Ion Versus Photon Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer

Inclusion Criteria

• •1. All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol.
• •2. Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration
• •3. Unresectable by radiographic or exploration within 30 days of registration
• •4. Age ≥ 18 years.
• •5. Distance from the pancreas tumor edge to the bowel and stomach \> 3 mm (in both the prone and supine positions)
• •6. Tumor does not exceed 15 cm in greatest dimension
• •7. No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen and pelvis OR by 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.
• •8. Zubrod performance status of 0-1, within 30 days prior to registration.
• •9. Adequate hematologic, renal, and liver function as defined by:Adequate hematologic, renal, and liver function as defined by:
• •Absolute neutrophil count \> 1500 cells/mm3 Creatinine \<1.5 mg/dL Hemoglobin ≥ 8.0 g/dL AST and ALT \< 2.5 X ULN Bilirubin ≤ 1.5 times the ULN (after stent placement, if necessary)
• •10. Patients must complete all required pretreatment evaluations
• •11. Able to travel to a foreign country within approximately 4 weeks of randomization (for patients enrolled outside of Japan and Italy)
• •12. 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.
• •13. 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).