Resectable Pancreatic AdenocarcinomaPhase 2NCT05066802
A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing neoadjuvant modified FOLFIRINOX in people with Resectable Pancreatic Adenocarcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Resectable Pancreatic Adenocarcinoma
- What is being tested?
- neoadjuvant modified FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2020to 31 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination
- Pancreatic adenocarcinoma patients evaluated as resectable according to the following criteria in imaging tests including CT or MRI (NCCN guideline criteria, if all of the following criteria are satisfied) A. No tumor contact with the major arterial structures of the Celiac axis [CA], superior mesenteric artery [SMA], and common hepatic artery [CHA].
- When there is no contact between the tumor and the major vein of the superior mesenteric vein (SMV) or portal vein (PV), or within 180° even if there is contact, and there is no venous atypicality.
- Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.
- Patients whose ECOG activity ability index is 0 to 1
- Patients who are willing and able to provide written informed consent for this study.
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- Patients over the age of 19 at the time of signing the subject consent form.
- Patients with evaluable lesions according to RECIST 1.1.
- Patients with adequate organ function.
Who cannot join
- Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
- Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
- Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
- Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or used investigational drugs or medical devices within 4 weeks prior to the first administration of this investigational drug.
- Those who received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient.
- Patients with known aggravation within the past 3 years or other malignant tumors requiring active treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea
Seoul
Choong-kun Lee, +82-2-2228-8133, cklee512@yuhs.ac
About this study
Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical resection for localized PDAC. Even with superior survival among various disease extent of PDAC, resectable PDAC still shows poor outcomes with surgery followed by adjuvant chemotherapy. This phase II study is investigating the role of modified-FOLFIRINOX as neoadjuvant treatment for resectable PDAC.
Read the detailed description
This phase II study is designed to evaluate the efficacy and safety of modified FOLFIRINOX as neoadjuvant treatment for resectable pancreatic cancer.
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Being tested
- neoadjuvant modified FOLFIRINOX
- Keywords
- resectable pancreatic cancer, Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant modified FOLFIRINOXDrug
oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks) before surgery.
| Study group | Role | What they receive |
|---|---|---|
| modified FOLFIRINOX | Experimental | oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks). Receives: Drug: neoadjuvant modified FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection Rate
R0 resection rate with pathology report after curative aim surgery.
Measured: Post surgery (within one week)
Secondary outcomes (4)
overall survival
overall survival is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.
Measured: up to 2 years
Progression Free Survival
Progression Free Survival is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up
Measured: up to 2 years
disease-free survival
disease-free survival is defined as time interval from operation day to tumor progression/death/last follow-up
Measured: up to 2 years
Objective response rate
Objective response rate is defined as rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start11 May 2020
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Choong-kun Lee, Principal investigator, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066802
- Sponsor's protocol ID
- 4-2019-0485
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 4 Oct 2021
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05066802
- Acronym / sponsor ID
- 4-2019-0485
- Conditions
- Resectable Pancreatic Adenocarcinoma
- Keywords
- resectable pancreatic cancer, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 4 Oct 2021 (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.
Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical resection for localized PDAC. Even with superior survival among various disease extent of PDAC, resectable PDAC still shows poor outcomes with surgery followed by adjuvant chemotherapy. This phase II study is investigating the role of modified-FOLFIRINOX as neoadjuvant treatment for resectable PDAC.
Detailed description
This phase II study is designed to evaluate the efficacy and safety of modified FOLFIRINOX as neoadjuvant treatment for resectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified FOLFIRINOX | Experimental | Drug: neoadjuvant modified FOLFIRINOXoxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination
- Pancreatic adenocarcinoma patients evaluated as resectable according to the following criteria in imaging tests including CT or MRI (NCCN guideline criteria, if all of the following criteria are satisfied) A. No tumor contact with the major arterial structures of the Celiac axis [CA], superior mesenteric artery [SMA], and common hepatic artery [CHA].
- Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.
- Patients whose ECOG activity ability index is 0 to 1
- Patients who are willing and able to provide written informed consent for this study.
Key exclusion criteria (6 listed)
- Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
- Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
- Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
- Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or used investigational drugs or medical devices within 4 weeks prior to the first administration of this investigational drug.
- Those who received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient.
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 |
|---|---|---|
| neoadjuvant modified FOLFIRINOXoxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks) before surgery. | Drug | modified FOLFIRINOX |
Primary outcome
R0 Resection Rate
Time frame: Post surgery (within one week)
R0 resection rate with pathology report after curative aim surgery.
4 secondary outcomes
overall survival
Time frame: up to 2 years
Progression Free Survival
Time frame: up to 2 years
disease-free survival
Time frame: up to 2 years
Objective response rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- 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. This study is not recruiting at the moment.
Choong-kun Lee principal investigator
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant modified FOLFIRINOX in people with Resectable Pancreatic Adenocarcinoma, run by Yonsei University at 1 site 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choong-kun Lee (+82-2-2228-8133, cklee512@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate (time frame: Post surgery (within one week)). 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 4 Oct 2021.