A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion.

UMIN ID: UMIN000055760

Registered date:08/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: pancreatic body and tail adenocarcinoma
• Date of first enrollment: 2024/11/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Overall survival after initiation of protocol treatment
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Tokai University School of Medicine
• Source(s) of Monetary Support: Tokai University School of Medicine