Pancreatic carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 Years; 2. Performance status: Karnofsky=70% (ECOG 0-2); 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas; 4. Locally advanced, unresectable disease, defined by all of the following: (1) Obvious encasement of the celiac, hepatic, or superior mesenteric artery; (2) Encasement of the portal or superior mesenteric vein not amenable to surgical resection; (3) Extra pancreatic extension with or without regional lymph node involvement; (4) No evidence of distant metastatic disease by PET/CT and abdominal MRI; 5. Life expectancy: more than 3 months; 6. Tolerance fixed position for more than 30 minutes; 7. Hematological and Biochemical indexes: (1) Absolute neutrophil count = 1,500*10^9/L; (2) Platelet count =100*10^9/L; (3) Hemoglobin =9.0 g/dl; (4) Bilirubin = 1.5 times upper limit of normal; (5) AST and ALT = 2.5 times upper limit of normal; (6) Creatinine = 1.25 times upper limit of normal; (7) Creatinine clearance = 60 mL/min; 8. Other: If patients have biliary obstruction, they must have drainage prior to starting treatment.
Exclusion criteria
Exclusion criteria: 1.Prior therapy for pancreatic cancer. (includetargeted therapy, chemotherapy, radiotherapy, interventional therapy, etc.) 2.Complete or incomplete gastrointestinal obstruction. 3.Known allergies for gemcitabine or related ingredients. 4.Other history of malignant cancer in the past five years. Unless: 1) only surgical treatment of malignant tumor and its disease-free survival to 5 years; 2) had be curing skin basal cell carcinoma or the uterine cervix cancer in situ. 5.Pregnant or nursing female. 6.Fertile patients refuse to use effective contraception 7.Any unstable systemic disease. (includeHypertension, unstable angina pectoris, symptomatic congestive heart failure, cardiac arrhythmia, renal failure and so on) 8.Concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Local control rate;Objective remission rate;Progression free survival;Toxic and side effects; | — |
Primary
| Measure | Time frame |
|---|---|
| over survival; | — |
Countries
China
Contacts
Department of radiotherapy and oncology, Air Force General Hospital of PLA