Adjuvant ChemotherapyNCT06389552
Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients
An observational study of Adjuvant Chemotherapy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adjuvant Chemotherapy
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to Dec 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 110
Who may be able to join
- Age over 19 at the time of obtaining the informed consent form
- Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery
- ECOG 0 or 1
- Scheduled to RO or R1 resection
- Organ function capable of chemotherapy
Who cannot join
- FOLFIRINOX contraindications among the drug approval requirements
- Palliative Therapy
- Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul ST. Mary's Hospital
Seoul
Myung-Ah Lee
Myung-Ah Lee
About this study
Official title: A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective
This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.
Read the detailed description
This study is multi-center, prospective, long-term follow-up observational study.
- Conditions
- Adjuvant Chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Duration of survival before pancreatic cancer recurrence or death
Measured: Day 1 to Week 88
Secondary outcomes (1)
Overall survival
Duration of overall survival
Measured: Day 1 to Week 88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start25 Sep 2023
- Primary completionDec 2026 (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 Adjuvant ChemotherapyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Ah Lee, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389552
- Sponsor's protocol ID
- IN_CTP_N01
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective
- ClinicalTrials.gov ID
- NCT06389552
- Acronym / sponsor ID
- IN_CTP_N01
- Conditions
- Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (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.
This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.
Detailed description
This study is multi-center, prospective, long-term follow-up observational study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 110
Key inclusion criteria (5 listed)
- Age over 19 at the time of obtaining the informed consent form
- Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery
- ECOG 0 or 1
- Scheduled to RO or R1 resection
- Organ function capable of chemotherapy
Key exclusion criteria (3 listed)
- FOLFIRINOX contraindications among the drug approval requirements
- Palliative Therapy
- Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: Day 1 to Week 88
Duration of survival before pancreatic cancer recurrence or death
1 secondary outcome
Overall survival
Time frame: Day 1 to Week 88
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 29 Apr 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 study chair
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adjuvant Chemotherapy, run by HK inno.N Corporation 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 5 inclusion and 3 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 29 Apr 2024. 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.
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 Soyeon Ahn (82-2-6477-0252, soyeon.ahn@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: Day 1 to Week 88). 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 29 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.