Pancreatic Cancer ResectableNCT06809374
Investigation of the Optimal Duration of Neoadjuvant Therapy for Resectable Pancreatic Cancer
An observational study of Pancreatic Cancer Resectable, run by Kochi University.
Trial summary
Investigating the Optimal Duration of Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer to Determine the True Surgical Indication. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- gemcitabine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2024
- How long will I take part?
- 100 Years
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: radiologically resectable pancreatic cancer patients
Who may be able to join
- radiologically resectable pancreatic cancer patients
Who cannot join
- a body weight loss of greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal, or heart disease
About this study
Investigating the Optimal Duration of Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer to Determine the True Surgical Indication.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
neoadjuvant therapy for resectable pancreatic cancer using gemcitabine +S1 or gemcitabine + nab-Paxitaxel
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating the Presence of Occult Metastatic Lesions Detected During Neoadjuvant Therapy.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809374
- Sponsor's protocol ID
- iON study
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Optimal Duration of Neoadjuvant Therapy for Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06809374
- Acronym / sponsor ID
- iON study
- Conditions
- Pancreatic Cancer Resectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (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.
Investigating the Optimal Duration of Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer to Determine the True Surgical Indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- radiologically resectable pancreatic cancer patients
Key inclusion criteria (1 listed)
- radiologically resectable pancreatic cancer patients
Key exclusion criteria (1 listed)
- a body weight loss of greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal, or heart disease
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 |
|---|---|---|
| gemcitabineneoadjuvant therapy for resectable pancreatic cancer using gemcitabine +S1 or gemcitabine + nab-Paxitaxel | Drug | – |
Primary outcome
Investigating the Presence of Occult Metastatic Lesions Detected During Neoadjuvant Therapy.
Time frame: within 6 months
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 5 Feb 2025.
- 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 Resectable, run by Kochi University.
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 1 inclusion and 1 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 5 Feb 2025. 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?
Investigating the Presence of Occult Metastatic Lesions Detected During Neoadjuvant Therapy. (time frame: within 6 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 5 Feb 2025.