NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)
NCT ID: NCT05529940
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
609 participants
INTERVENTIONAL
2023-04-01
2027-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoadjuvant FOLFIRINOX
6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX
Folfirinox
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.
Upfront Surgery
surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX
Folfirinox
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.
Interventions
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Folfirinox
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.
Eligibility Criteria
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Inclusion Criteria
* 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 I. Women of childbearing potential must have a negative serum pregnancy test within one week before starting the intervention drug. Men and women of childbearing potential must use effective contraception from screening through six months after the last dose.
Exclusion Criteria
A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination (The resectability assessment depends on the presence of major vessel invasion, while invasion of adjacent organs is excluded from the criteria) 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, including active or ongoing systemic infections, symptomatic congestive heart failure, unstable angina, clinically significant cardiac arrhythmias, psychiatric disorders, or uncontrolled comorbid conditions that may limit compliance with study requirements, or any medical condition that, at the discretion of the investigator, could compromise patient safety, interfere with the assessment of safety and efficacy, or hinder participation in the clinical trial.
19 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Gangnam Severance Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Jin-Young Jang
Professor
Principal Investigators
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Wooil Kwon
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine
Seoul, , South Korea
Department of Surgery, Seoul National University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Myung-Ah Lee, M.D., Ph.D.
Role: backup
Se Jun Park, M.D.
Role: backup
Jin- Young Jang, M.D., PhD.
Role: backup
Wooil Kwon, M.D., PhD.
Role: backup
Other Identifiers
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H-2211-115-1380
Identifier Type: -
Identifier Source: org_study_id