Actively Recruiting
NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)
Led by Seoul National University Hospital · Updated on 2024-11-27
609
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
S
Seoul National University Bundang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 80 years old
- ECOG performance status of 0 or 1
- Diagnosis of pancreatic ductal adenocarcinoma confirmed by histology or cytology
- Imaging shows resectable pancreatic cancer with no arterial tumor contact and limited vein contact without irregularity
- No distant metastases on imaging
- Adequate bone marrow function: WBC ≥ 3000/mm3 or ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3
- Adequate liver function: Bilirubin ≤ 3 times upper normal limit (≤ 5.0 mg/dL), AST/ALT ≤ 5 times upper normal limit (< 200 IU/L)
- Adequate kidney function: Creatinine clearance ≥ 60 mL/min or creatinine < 1.5 times upper normal limit
- Physically able to undergo surgery
- Signed informed consent
- Women of childbearing potential must have a negative pregnancy test within one week before starting treatment
- Men and women of childbearing potential must use effective contraception during the study and for six months after the last dose
You will not qualify if you...
- Borderline resectable or locally advanced pancreatic cancer on imaging
- Previous pancreatic surgery
- Previous chemotherapy or radiation therapy for pancreatic cancer
- Distant metastases or recurrent pancreatic cancer
- Pancreatic cancer in body or tail requiring combined resection of adjacent organs except adrenal gland
- Diagnosis of other cancers within past five years except treated non-melanoma skin cancer or carcinoma in situ without disease
- Pregnant or breastfeeding women
- Serious systemic illnesses such as active infections, heart failure, unstable angina, significant arrhythmias, psychiatric disorders, or uncontrolled conditions that may affect safety or study participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine
Seoul, South Korea, 06591
Actively Recruiting
2
Department of Surgery, Seoul National University College of Medicine
Seoul, South Korea, 110-744
Actively Recruiting
Research Team
J
Jin-Young Jang
CONTACT
M
Myung-Ah Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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