Locally Advanced Pancreatic Cancer
Conditions
Interventions
Carbon-ion radiotherapy with a total of 55.2Gy(RBE), consisting of 12 fractions for 4.6Gy(RBE) each Chemotherapy with gemcitabine (1000mg/m2/week) for 3 weeks
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as invasive pancreatic ductal adenocarcinoma by cytology (*1) or histopathology *1: Class IV or V for cytology 2) No metastasis found by imaging studies: N0-1M0 3) Invasion into celiac trunk or superior mesenteric artery observed in abdominal CT or MRI: T4(UICC) 4) 20 years old or older and 80 years old or less of age at trial registration 5) 0 to 2 of Performance Status(ECOG) 6) No prior treatment of surgical resection (*2), chemotherapy or radiotherapy for pancreatic cancer *2: Except for single laparotomy, gastrojejunostomy and choledochojejunostomy 7) Patients fulfilled all the following criteria of clinical laboratory. The clinical laboratory test should be performed within 7 day before registration. (a) 3500/mm3 or more of white blood cell count (b) 9.0g/dl or more of hemoglobin concentration (c) 100000/mm3 or more of platelet count (d) 3.0g/dL or more of albumin (e) Total bilirubin *2 mg/dl or more if subjects underwent no biliary drainage *3 mg/dl or more if subjects underwent biliary drainage (f) GOT (AST) *100 IU or more if subjects underwent no biliary drainage *150 IU or more if subjects underwent biliary drainage (g) 1.2mg/dL or less of serum creatinine 8) No eligibility for other clinical studies on the Advanced Medical Care B(Senshin-Iryo B) 9) Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Finding of direct invasion in gastrointestinal duct as followings: (a) Obvious finding of invasion in the stomach or duodenum in gastrointestinal endoscopy (b) Invasive lesion protruding inside of gastrointestine in imaging studies such as computed tomography (CT) 2) Ascites found by the abdominal-pelvic CT 3) Gastric or duodenal ulcer except for ulcer scar 4) Patient with metallic stent for occlusive jaundice 5) Open wound or active and intractable infection in the target lesion of irradiation 6) Severe complications such as severe stroke, diabetes, heart disease, angina, myocardial infarction developed within 3 months, severe liver dysfunction and psychologic disease 7) Active double cancer including concurrent or metachronous tumor within two years, except for lesion equivalent to carcinoma in situ or intramucosal cancer which is completely treated by local therapeutic procedure. 8) Previous history of radiotherapy for targeted lesion 9) Conditions that attending physicians consider unsuitable for this clinical study due to medical or psychological issues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Local control period 2) Progression free period 3) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Katoh
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center
Outcome results
None listed