Pancreatic ductal adenocarcinoma
Conditions
Interventions
[Gemcitabine]
For both the GS and GS-RT groups, the prescribed dose (1,000 mg/m2) is administered intravenously on days 1, 8, 22, and 29 according to body surface area.
[S-1]
(1) GS therapy group
The
Sponsors
Eguchi Hidetoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients histologically and/or cytologically diagnosed as pancreatic ductal adenocarcinoma (PDAC) (2) Patients aged 18 years or older at the time of consent (3) Patients with ECOG PS of 0-1 (4) Patients who are judged to have resectable PDAC based on imaging diagnosis, etc. Patients are evaluated for the possibility of radical resection by CT with a thickness of at least 5 mm or less. MRI, ultrasonography, PET/CT, laparoscopy, etc. are performed as necessary. Diagnosis of resectable PDAC is made when the following imaging findings are present. (i) No tumor contact/invasion in the portal vein/superior mesenteric vein, or contact/invasion less than 180 degrees but resectable (ii) No contact/invasion of the inferior vena cava (iii) No tumor contact/invasion in the aorta, celiac artery, common hepatic artery, or superior mesenteric artery (5) Patients who will receive this treatment as the first treatment for PDAC (6) Patients who are expected to survive for at least 6 months from the time consent is obtained (7) Patients with no evidence of tumor invasion into the gastrointestinal tract (8) Patients whose major organ functions (bone marrow, liver, kidney, lungs, etc.) are maintained - White blood cell count: 3,500/mm3 or higher - Neutrophil count: 2,000/mm3 or higher - Platelet count: 100,000/mm3 or higher - Hemoglobin: 9.0 g/dL or higher - Total bilirubin: 2.0 mg/dL or less (3.0 mg/dL or lower for patients treated for obstructive jaundice) - AST (GOT), ALT (GPT): 150 U/L or less - Serum creatinine level: 1.2 mg/dL or less, creatinine clearance: 60 mL/min or more (9) Patients who provide written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: (1) Patients with unresectable PDAC who meet the following conditions (i) Distant metastasis (ii) Peritoneal dissemination and/or positive intraperitoneal cytology (iii) Paraaortic lymph node metastasis (iv) Contact/invasion of portal vein/superior mesenteric vein more than 180 degrees (v) Contact/invasion of aorta, superior mesenteric artery, celiac artery, or common hepatic artery (2) Patients with pulmonary fibrosis and/or interstitial pneumonia, a history of pulmonary fibrosis and/or interstitial pneumonia, or CT findings that are suspicious of these conditions. Patients with severe emphysema or old inflammatory changes, or with significantly impaired respiratory function on pretreatment respiratory function tests (3) Patients with active infection (excluding cholangitis and viral hepatitis) (4) Patients with serious complications (e.g., heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes) (5) Patients with ascites or pleural effusion of moderate severity or greater (e.g., requiring puncture) (6) Patients with active multiple cancers (simultaneous multiple cancers or multiple cancers with a disease-free period of 2 years or less). However, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma considered as curable by local treatment is not considered as an active overlapping cancer (7) Patients using flucytosine, phenytoin, or warfarin potassium (8) Women who are pregnant, may become pregnant, wish to become pregnant, or are breastfeeding. Males whose partners wish to become pregnant (9) Patients with serious drug hypersensitivity (10) Patients who are currently participating in another interventional study (11) Patients who are deemed inappropriate as research subjects by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Resection rate (2) R0 resection rate (3) Histological effect of preoperative treatment (4) Progression-free survival (5) Grade 3 or higher adverse events | — |
Contacts
Public ContactYoshito Tomimaru
The University of Osaka Hospital
Outcome results
None listed