NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Trial Title: NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

NCT ID: NCT05529940

Condition: Resectable Pancreatic Cancer
Neoadjuvant Chemotherapy
Effects of Chemotherapy

Conditions: Official terms:
Pancreatic Neoplasms
Folfirinox

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Folfirinox
Description: The primary aim of this trial was to investigate whether six cycles of preoperative mFOLFIRINOX followed by six cycles of postoperative mFOLFIRINOX improved the overall survival rate by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.
Arm group label: Neoadjuvant FOLFIRINOX
Arm group label: Upfront Surgery

Summary: Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC. Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX. Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1. Intervention: Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat

Criteria for eligibility:
Criteria:
Inclusion Criteria: - A. Age: 19 to 80 years old B. Patients with a score of 0 - 2 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021) - No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery). - No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity. E. No distant metastases on preoperative imaging F. Patients with adequate organ function 1. Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3 2. Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (<200 IU/L) 3. Renal function (Cr clearance ≥ 60 mL/min) or (Cr < 1.5 x upper normal limit) G. Persons physically capable of undergoing surgery H. Those who consented to the clinical trial Exclusion Criteria: - Patients who met any of the following criteria are not eligible to participate in this study. A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination B. Patients with a history of previous pancreatic surgery C. Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer D. Patients with distant metastases or recurrent pancreatic cancer E. Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland) F. 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) G. Pregnant and lactating women H. 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

Gender: All

Minimum age: 19 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Contact:
Last name: Myung-Ah Lee, M.D., Ph.D.

Phone: +82-3210-3125
Email: angelamd@gatholic.ac.kr

Investigator:
Last name: Myung-Ah Lee, M.D., Ph.D.
Email: Principal Investigator

Investigator:
Last name: Se Jun Park, M.D.
Email: Sub-Investigator

Facility:
Name: Department of Surgery, Seoul National University College of Medicine

Address:
City: Seoul
Zip: 110-744
Country: Korea, Republic of

Start date: September 2023

Completion date: December 2027

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Collaborator:
Agency: Seoul St. Mary's Hospital
Agency class: Other

Collaborator:
Agency: Seoul National University Bundang Hospital
Agency class: Other

Collaborator:
Agency: SMG-SNU Boramae Medical Center
Agency class: Other

Collaborator:
Agency: Gangnam Severance Hospital
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05529940