Resectable Pancreatic CancerPhase 3NCT05529940
NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)
A Phase 3 study testing Folfirinox in people with Resectable Pancreatic Cancer and Neoadjuvant Chemotherapy, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Resectable Pancreatic Cancer, Neoadjuvant Chemotherapy, Effects of Chemotherapy
- What is being tested?
- Folfirinox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Apr 2023to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A. Age: 19 to 80 years old B. Patients with a score of 0 - 1 (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.
- No distant metastases on preoperative imaging F. Patients with adequate organ function
- Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3
- Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (<200 IU/L)
- 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.
Who cannot join
- Patients who met any of the following criteria are not eligible to participate in this study.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Myung-Ah Lee contact
South Korea2 sites, 2 recruiting
- Recruiting
Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine
Seoul, 06591
Myung-Ah Lee, M.D., Ph.D., +82-3210-3125, angelamd@gatholic.ac.kr
Myung-Ah Lee, M.D., Ph.D.
- Recruiting
Department of Surgery, Seoul National University College of Medicine
Seoul, 110-744
Jin- Young Jang, M.D., PhD., 82-2-2072-2194, jangjy4@gmail.com
Wooil Kwon, M.D., PhD., 82-2-2072-2817, willdoc78@gmail.com
About this study
Official title: Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)
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.
Read more
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
- Being tested
- Folfirinox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolfirinoxDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant FOLFIRINOX | Experimental | 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Receives: Drug: Folfirinox |
| Upfront Surgery | Active comparator | surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Receives: Drug: Folfirinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival rate
The primary objective of this trial is 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.
Measured: 2 years
Secondary outcomes (7)
Overall survival
Defined as the time from the date of randomization to the date of death from any cause. Patients who were not reported dead at the time of analysis were censored on the last day they were known to be alive.
Measured: 5 years
Disease free survival
Defined as the time between the date of randomization and the occurrence of distant metastases, locoregional progression, or death from any cause. Patients who were alive and free of these events at the last follow-up would be censored.
Measured: 3 years
Resection rate
Referred to the proportion of patients who underwent curative resection
Measured: 3 years
R0 resection rate
Referred to the proportion of patients with microscopically negative resection margins due to the pathological examinations after the surgery. In this case, R0 indicated that no tumor was observed within 0 mm from the margins of resection.
Measured: 3 years
Local recurrence rate
Local recurrence is defined as recurrence in the pancreatic resection margin, residual pancreas, and regional lymph nodes, and distant metastasis is defined as recurrence in a distant organ. The local recurrence and distant metastasis rates are defined as the percentage of patients who had recurrence after the surgical resection.
Measured: 3 years
Recurrence rate
The proportion of patients who experienced recurrence within two years from the date of surgery.
Measured: 2 year
Response rate in neoadjuvant setting
Defined as the percentage of patients who showed complete response, partial response, and stable disease after three or six cycles of scheduled chemotherapy. The evaluation is based on RECIST v.1.1.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 609 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gangnam Severance Hospital, Seoul St. Mary's Hospital
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
- Investigators
- Wooil Kwon, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529940
- Sponsor's protocol ID
- H-2211-115-1380
- Status last verified
- Nov 2024
- First submitted
- 2 Sep 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)
- ClinicalTrials.gov ID
- NCT05529940
- Acronym / sponsor ID
- H-2211-115-1380
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 609 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gangnam Severance Hospital, Seoul St. Mary's Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant FOLFIRINOX | Experimental | Drug: Folfirinox6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX |
| Upfront Surgery | Active comparator | Drug: Folfirinoxsurgical resection followed by 12 cycles of adjuvant mFOLFIRINOX |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A. Age: 19 to 80 years old B. Patients with a score of 0 - 1 (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.
- No distant metastases on preoperative imaging F. Patients with adequate organ function
- Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3
Key exclusion criteria (2 listed)
- Patients who met any of the following criteria are not eligible to participate in this study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FolfirinoxThe 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. | Drug | Neoadjuvant FOLFIRINOX, Upfront Surgery |
Primary outcome
2-year survival rate
Time frame: 2 years
The primary objective of this trial is 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.
7 secondary outcomes
Overall survival
Time frame: 5 years
Disease free survival
Time frame: 3 years
Resection rate
Time frame: 3 years
R0 resection rate
Time frame: 3 years
Local recurrence rate
Time frame: 3 years
Recurrence rate
Time frame: 2 year
Response rate in neoadjuvant setting
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myung-Ah Lee contact
Wooil Kwon study director
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folfirinox in people with Resectable Pancreatic Cancer and Neoadjuvant Chemotherapy, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Jang (+82-2-2072-2194, jyjang4@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.