Trial summary: This study investigates whether administering chemotherapy before surgery, known as neoadjuvant chemotherapy, can improve outcomes for individuals with resectable pancreatic cancer.
Status: OPEN - Recruiting
Trial identifier: ACTRN12624000005550p
Sponsor: Seoul National University
Phase: III
Diagnosis: Resectable pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: Surgery with mFOLFIRINOX chemotherapy
  • Key inclusion criteria
    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):
      • There is no arterial tumour contact (celiac artery, superior mesenteric artery, or common hepatic artery).
      • There is no tumour contact with the superior mesenteric vein or portal vein or ≤ 180° contact without vein contour irregularity.
    5. No distant metastases on preoperative imaging
    6. Patients with adequate organ function:
      • Bone marrow function: WBC ≥ 3,000/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet ≥ 100 K/mm3
      • Liver function: bilirubin ≤ 3 × the upper normal limit (≤ 5.0 mg/dL), AST/ALT ≤ 5 the upper normal limit (< 200 IU/L)
      • Renal function: Creatinine clearance (Cr) ≥ 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
  • Key exclusion criteria
    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

NeoFOL-R

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill).

Epworth PI: Mr Julian Choi

Jreissati Pancreatic Centre at Epworth 

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Please contact us for more information on 03 9426 8880 or email [email protected]


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