Patients with locally advanced pancreatic cancer (BR-A or UR-LA) scheduled for pancreatic resection
Conditions
Interventions
Preoperative chemoradiotherapy using gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer after primary chemotherapy. gemcitabine plus nab-paclitaxel therapy: gemcitabine plus nab-p
Sponsors
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pancreatic cancer (invasive ductal carcinomas) diagnosed by imaging and pathological examination 2) No evidence of distant metastasis 3) Patients diagnosed with BR-A or UR-LA pancreatic cancer, who have received at least 3 courses of gemcitabine plus nab-paclitaxel as primary chemotherapy, whose efficacy is judged to be CR/PR/SD, and who are technically considered to be resectable and are planning to undergo surgery. 4) Age: between 20 and 80 years old 5) Performance status (ECOG): 0 or 1 6) Tumor is measurable on imaging CT 7) No history of chemotherapy, hormonal therapy, or molecular targeted therapy other than the above 8) No history of radiation therapy to the abdomen 9) Appropriate biliary drainage is performed in cases of obstructive jaundice. 10) No direct invasion of the gastrointestinal tract on imaging findings 11) No evidence of concurrent cancer of other organs 12) adequate major organ function (1) Leukocyte count: >=3500 /mm3, <12000 /mm3 (2) Neutrophil count: >=2000 /mm3 (3) Hemoglobin: >=9.0 g/dL (4) Platelet count: >=100000 /mm3 (5) Total bilirubin: <=2.0 mg/dL (<=3.0 mg/dL: patients undergoing drainage for obstructive jaundice) (6) AST: <=150 U/L, ALT: <=150 U/L (7) Creatinine: <=1.2 mg/dL (8) Creatinine clearance: >=50 mL/min 13) Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1) Active multiple cancers 2) Patients whose dose of GEM+nab-PTX in primary chemotherapy was reduced to less than 600 mg/m2 of GEM or less than 75 mg/m2 of nab-PTX 3) Patients who were refractory or intolerant to primary GEM+nab-PTX and were switched to other chemotherapy 4) Infection or inflammation that requires systemic treatment 5) Fever of 38.0 degrees Celsius higher at the time of registration 6) Allergy or contraindication to gemcitabine or paclitaxel 7) History of severe drug hypersensitivity or drug allergy 8) Allergy to contrast media 9) History of serious heart disease 10) History of serious underlying diseases (poorly controlled diabetes, renal failure, liver cirrhosis, etc.) 11) Poorly controlled ascites or pleural effusion 12) Active gastrointestinal bleeding requiring repeated blood transfusions. 13) Diarrhea (more than 4 times a day or watery stools) 14) Poorly controlled cancer pain 15) Pulmonary fibrosis or interstitial pneumonia with obvious or clinical findings on imaging 16) Lung field enters the radiation field 17) Pregnant or lactating women or those with the potential (intention) to become pregnant 18) Severe psychological or neurological disease 19) Unable to give consent to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study: Incidence of dose-limiting toxicities (DLT) Phase II study: 2-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I study: Response rate Disease control rate Safety (incidence and severity of adverse events) Phase II study: Overall survival Progression-free survival Response rate Disease control rate Tumor marker decrease rate Surgical procedure Intraoperative blood loss Operation time Resection rate R0 resection rate Incidence of postoperative pancreatic fistula Postoperative hemorrhage Incidence of DGE Incidence of diarrhea Other postoperative complications Safety (incidence and severity of adverse events) | — |
Countries
Japan
Contacts
Public ContactKazuto Shibuya
Faculty of Medicine, Academic Assembly, University of Toyama Department of Surgery and Science
Outcome results
None listed