Carbon Ion RT for Locally Advanced Pancreatic Cancer

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
• Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
• Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) orsurgical exploration within 30 days prior to registration, defined based on at leastone of the following: major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximalhepatic artery abutment of the celiac trunk
• No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of thechest, abdomen, and pelvis within 30 days prior to registration
• ECOG Performance Status 0-1 within 30 days prior to registration
• Age ≥ 18
• CBC/differential obtained within 14 days prior to step 1 registration, with adequatebone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieveHgb ≥ 9.0 g/dl is acceptable)
• Additional laboratory studies within 14 days prior to registration demonstrating: Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)
• Bilirubin < 1.5 x ULN
• ALT and AST ≤ 2.5 x ULN
• aPTT, PT ≤ 1.5 x ULN
• Patients must provide study specific informed consent prior to study entry.
• Women of childbearing potential and male participants must practice adequatecontraception during protocol treatment and for at least 6 months following treatmentFor females of child-bearing potential, negative serum pregnancy test within 30 daysprior to registration

Exclusion Criteria:

• More than one primary lesion
• Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
• Active malignancy, other than pancreatic cancer, for which systemic therapy isindicated. -History of adequately treated local basal cell or squamous cell carcinomaof the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomaticprostate cancer without known metastatic disease and with no requirement for therapyasides from hormonal therapy, adequately treated stage 1or 2 cancer currently incomplete remission, or any other cancer that has been in complete remission for ≥ 5years is permitted.
• Prior treatment for pancreatic cancer with surgical resection, external radiotherapy,or interstitial isotope implantation.
• Prior treatment for pancreatic cancer with a systemic therapy regimen/agent notincluded in the list below. Systemic therapy must be discontinued at least 14 daysbefore study enrollment.
• FOLFIRINOX
• Gemcitabine/nab-paclitaxel
• Gemcitabine
• S-1
• Prior radiation therapy to the abdomen that would result in overlap of radiationtherapy fields