Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas
- The American Joint Committee on Cancer (AJCC) stage I-III with unresectable or borderline unresectable disease as defined by NCCN guidelines
Radiological resectability is defined by the following criteria on abdominal imaging:
- No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery.
- No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
- No evidence of visceral or peritoneal metastases
- Borderline and Unresectable cases would be defined as those that do not meet the criteria in section and also show no evidence of distant metastatic or intraperitoneal disease.
- Eastern Cooperative Oncology Group performance status of ≤ 2
- Age > 18 years
- Adequate hematologic reserve, hepatic reserve and renal function
- White Blood Cell (WBC) > 2,000 cells/mm3
- Absolute Neutrophil Count (ANC) > 1,500 cells/mm3
- Platelets > 100,000 cells/mm3
- Serum bilirubin ≤ 2.5 mg/dL
- Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min
- Alanine aminotransferase (ALT) < 3 times ULN
- Aspartate transaminase (AST) < 3 times ULN
- Albumin > 3.2 g/dl
- Patient must sign study-specific informed consent
Exclusion Criteria:
- AJCC stage IV with metastatic disease
- Eastern Cooperative Oncology Group performance status of > 2
- Age < 18 years
- WBC < 2,000 cells/mm3
- ANC < 1,500 cells/mm3
- Platelets > 100,000 cells/mm3
- Serum bilirubin > 2.5 mg/dL
- Serum creatinine > 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min
- ALT > 3 times ULN
- AST > 3 times ULN
- Albumin < 3.2 g/dl
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Experimental
Proton Radiation
Pre-Proton-chemotherapy (PCT) Patients will receive a combination of the agents (Gemcitabine plus Erlotinib) for 8 weeks prior to PCT Gemcitabine 1000 mg/m2 IV, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 PCT to be started in 4 to 8 weeks after completion of Pre-PCT Proton therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day for 5 ½ weeks. Chemotherapy: Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed Post-PCT to be started in 4 to 6 weeks after completion of PCT Oxaliplatin 130 mg/m2, day 1 Capecitabine 1000 mg/m2 po bid on days 2 to 15 for 14 days The CapOx regimen (Capecitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles