pancreatic body and tail adenocarcinoma
Conditions
Interventions
None listed
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Cases in which the primary lesion has been confirmed to be pancreatic cancer by histology, cytology, or imaging, and the extent of the disease has been diagnosed by imaging diagnosis, and among cases that meet the criteria for resectable pancreatic body and tail cancer in the NCCN Guidelines (Version 1.2020), those with unresectable pancreatic body and tail cancer with splenic artery and vein invasion by imaging diagnosis 2 Cases with measurable lesions 3 Cases undergoing initial treatment 4 Cases with performance status (ECOG)of 0 or 1 5 Cases aged 18 years or older at the time of consent 6 Cases whose major organ functions meet the following criteria(latest values within 14 days prior to enrollment) White blood cells: up to12,000/mm3 Neutrophils: over 1,500/mm3 Hemoglobin level: over 9.0g/dL Platelets: over 100,000 /mm3 Total bilirubin:less than 2.0mg/dL (less than 3.0mg/dL in cases of reduced jaundice) Serum creatinine: up to 1.5mg/dL AST and ALT: 2.5 X upper limit of facility standard or less 7 Patients who have signed consent to participate in this study prior to enrollment
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe drug hypersensitivity or drug allergy 2. Patients with a history of malignant tumors (Patients with a recurrence-free period of 5 years or more, and patients with endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin may be enrolled) 3. Patients with active infections 4. Patients with peripheral sensory neuropathy (Grade 2 or higher) 5. Patients with a history of interstitial pneumonia or pulmonary fibrosis 6. Patients with uncontrollable ascites or pleural effusion 7. Patients with uncontrollable diabetes mellitus 8. Patients with uncontrollable congestive heart failure, angina pectoris, hypertension, or arrhythmia 9. Patients with a history or comorbidity of significant neurological or psychiatric disease 10. Patients with diarrhea (including increased stool frequency and watery stools) 11. Pregnant women, lactating women, and those who may be pregnant (or intend to become pregnant), or those who have been pregnant for a certain period (180 days) during the clinical trial or after the final administration of the investigational drug Women and men who have no intention of using contraception. 12. Other cases that a doctor judges to be inappropriate for participation in the clinical trial. 13. Those whose stage of disease is diagnosed by MDCT and meets the Borderline Resectable/Unresectable criteria of the NCCN Guidelines (Version 1.2020). 14. Patients with active hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival after initiation of protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence-free survival after initiation of protocol treatment 2. Safety (adverse events) of protocol treatment (gemcitabine + nab-paclitaxel therapy) (CTCAE Ver 4.0.) 3. Rate of all surgical complications of Clavien-Dindo classification Grade III or higher during postoperative hospital stay 4. Response rate of preoperative chemotherapy (RECIST Ver1.1) and disease control rate 5. Tumor marker (CA19-9, CEA) normalization rate before and after preoperative chemotherapy 6. Reduction rate of SUVmax value of primary tumor by PET-CT examination 7. Histological treatment effect (Grade based on tumor cell disappearance rate according to Evans criteria) 8. Resection rate 9. Radical resection rate (R1 or R0; R1: no macroscopic residual cancer, R0: no histological residual cancer) 10. Surgery-related results (operation time, blood loss, transfusion, length of hospital stay after surgery) 11. Postoperative complication rate (reoperation rate, readmission rate within 90 days after discharge, surgery-related mortality) 12. Adjuvant chemotherapy initiation rate 13. Dose intensity | — |
Countries
Japan
Contacts
Public ContactYoshihito Masuoka
Tokai University School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed