Borderline Resectable Pancreatic CancerPhase 2NCT02717091
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
A Phase 2 study testing FOLFIRINOX and gemcitabine + nab-paclitaxel in people with Borderline Resectable Pancreatic Cancer, run by Nagoya University.
Trial summary
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Borderline Resectable Pancreatic Cancer
- What is being tested?
- FOLFIRINOX and gemcitabine + nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
- first treatment for pancreatic cancer
- performance status 0 or 1
- adequate one marrow function
- adequate renal function
- obtained informed consent
Who cannot join
- other active concomitant malignancies
- other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
- pregnant women
- no informed consent
About this study
Official title: Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
- Conditions
- Borderline Resectable Pancreatic Cancer
- Being tested
- FOLFIRINOX, gemcitabine + nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
gemcitabine + nab-paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | 4 course of FILFIRINOX before surgery Receives: Drug: FOLFIRINOX |
| GEM + nab-PTX | Experimental | 2 course of GEM + nab-PTX before surgery Receives: Drug: gemcitabine + nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
surgery is supposed to be performed 3 months after the initiation of chemotherapy
Measured: 3 months
Secondary outcomes (8)
completion rate of chemotherapy
chemotherapy is supposed to take 3 months
Measured: 3 months
relative dose intensity
chemotherapy is supposed to take 3 months
Measured: 3 months
adverse event
chemotherapy is supposed to take 3 months
Measured: 3 months
tumor response
tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable
Measured: 3 months
disease free survival
Measured: 3 years after the surgery
overall survival
Measured: 3 years after the surgery
surgical complication
Measured: 1 month after the surgery
quality of the tumor
Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value.
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 posted23 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2020
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junpei Yamaguchi, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717091
- Sponsor's protocol ID
- NUDC1508
- Status last verified
- Sep 2020
- First submitted
- 11 Feb 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02717091
- Acronym / sponsor ID
- NUDC1508
- Conditions
- Borderline Resectable Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- 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.
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: FOLFIRINOX4 course of FILFIRINOX before surgery |
| GEM + nab-PTX | Experimental | Drug: gemcitabine + nab-paclitaxel2 course of GEM + nab-PTX before surgery |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
- first treatment for pancreatic cancer
- performance status 0 or 1
- adequate one marrow function
- adequate renal function
Key exclusion criteria (4 listed)
- other active concomitant malignancies
- other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
- pregnant women
- no informed consent
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 |
|---|---|---|
| FOLFIRINOX | Drug | FOLFIRINOX |
| gemcitabine + nab-paclitaxel | Drug | GEM + nab-PTX |
Primary outcome
R0 resection rate
Time frame: 3 months
surgery is supposed to be performed 3 months after the initiation of chemotherapy
8 secondary outcomes
completion rate of chemotherapy
Time frame: 3 months
relative dose intensity
Time frame: 3 months
adverse event
Time frame: 3 months
tumor response
Time frame: 3 months
disease free survival
Time frame: 3 years after the surgery
overall survival
Time frame: 3 years after the surgery
surgical complication
Time frame: 1 month after the surgery
quality of the tumor
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 10 Sep 2020.
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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?
A Phase 2 study testing FOLFIRINOX and gemcitabine + nab-paclitaxel in people with Borderline Resectable Pancreatic Cancer, run by Nagoya 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 6 inclusion and 4 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 10 Sep 2020. 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.
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?
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?
R0 resection rate (time frame: 3 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 10 Sep 2020.