eoadjuvant chemotherapy in resectable pancreatic cancer

Phase 3

Recruiting

• Conditions: Pancreatic cancer; Cancer - Pancreatic

• Registration Number: ACTRN12624000005550
• Lead Sponsor: Epworth HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients must meet all of the following criteria to participate in this study.
1.Age: 18 – 80 years
2.Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 – 2
3.Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological)
4.Patients evaluated for resectable pancreatic cancer on preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)
a.There is no arterial tumour contact (celiac artery, superior mesenteric artery, or common hepatic artery).
b.There is no tumour contact with the superior mesenteric vein or portal vein or equal to or less than 180°contact without vein contour irregularity.
5.No distant metastases on preoperative imaging
6.Patients with adequate organ function
a)Bone marrow function: WBC greater or equal to 3,000/mm3 or absolute neutrophil count (ANC) greater or equal to 1,500/mm3, platelet greater or equal to 100 K/mm3
b)Liver function: bilirubin equal or less than 3 × the upper normal limit (equal to or less than 5.0 mg/dL), AST/ALT equal to or less than 5 the upper normal limit (less than 200 IU/L)
c)Renal function (Creatinine clearance (Cr) equal to or greater than 60 mL/min) or (Cr < 1.5 x upper normal limit)
7.Persons physically capable of undergoing surgery
8.Those who consented to the clinical trial

Exclusion Criteria

Patients who meet any of the following criteria are not eligible to participate in this study.
1)Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination
2)Patients with a history of previous pancreatic surgery
3)Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer
4)Patients with distant metastases or recurrent pancreatic cancer
5)Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland)
6)Patients within five years of diagnosis of other organ malignancies (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ without evidence of disease)
7)Pregnant and lactating women
8)Serious concomitant systemic disorders that would compromise the safety of the patient or patient's ability to complete the study at the discretion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in overall survival rate between individuals who receive mFOLFIRINOX before and after surgery, compared to those who only receive postoperative mFOLFIRINOX.[Survival data will be collected from review of medical records. The first follow-up visit will commence immediately after the completion of therapy, They will subsequently be performed every 4 months after the first day of the last postoperative chemotherapy cycle.]