Pancreatic CancerNCT06129812
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer
An observational study of Pancreatic Cancer and Neoadjuvant, run by Seoul National University Hospital.
Trial summary
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer, Neoadjuvant
- What is being tested?
- Neoadjuvant treatment
- Type of treatment
- Injection or infusion
- How many people
- 1,132 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
Who may be able to join
- Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
- Between January 2007 and June 2021 at Seoul National University Hospital
Who cannot join
- Patients who had borderline resectable PDAC with arterial invasion
- Patients who received chemotherapy as initial treatment and did not undergo surgery
- Incomplete follow-up data for analysis
About this study
Official title: An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer
Read the detailed description
The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.
- Conditions
- Pancreatic Cancer, Neoadjuvant
- Being tested
- Neoadjuvant treatment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant treatmentDrug
Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.
| Study group | Role | What they receive |
|---|---|---|
| resectable PDAC with no contact to major vessels (R-no contact) | Not described Receives: Drug: Neoadjuvant treatment | |
| resectable PDAC with contact PV/SMV of ≤180° (R-contact) | Not described Receives: Drug: Neoadjuvant treatment | |
| borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V) | Not described Receives: Drug: Neoadjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the time from diagnosis to death from any cause or the date of the last visit
Measured: From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startJan 2007
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129812
- Sponsor's protocol ID
- NAT in resectable PDAC
- Status last verified
- Sep 2023
- First submitted
- 27 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels
- ClinicalTrials.gov ID
- NCT06129812
- Acronym / sponsor ID
- NAT in resectable PDAC
- Conditions
- Pancreatic Cancer, Neoadjuvant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,132 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 13 Nov 2023 (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.
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer
Detailed description
The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| resectable PDAC with no contact to major vessels (R-no contact) | – | Drug: Neoadjuvant treatment |
| resectable PDAC with contact PV/SMV of ≤180° (R-contact) | – | Drug: Neoadjuvant treatment |
| borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V) | – | Drug: Neoadjuvant treatment |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
Key inclusion criteria (2 listed)
- Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
- Between January 2007 and June 2021 at Seoul National University Hospital
Key exclusion criteria (3 listed)
- Patients who had borderline resectable PDAC with arterial invasion
- Patients who received chemotherapy as initial treatment and did not undergo surgery
- Incomplete follow-up data for analysis
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 treatmentIntravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC. | Drug | borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V), resectable PDAC with contact PV/SMV of ≤180° (R-contact), resectable PDAC with no contact to major vessels (R-no contact) |
Primary outcome
Overall survival
Time frame: From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months
the time from diagnosis to death from any cause or the date of the last visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Neoadjuvant, run by Seoul National University Hospital.
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 2 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: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months). 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 13 Nov 2023.